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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic with DSRM

Meeting Date: 9/11/15-9/11/15

Meeting Details:

The committees will discuss new drug application (NDA) 208090, oxycodone extended-release capsules for oral use, submitted by Collegium Pharmaceuticals, proposed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate. This product has been formulated with the intent to provide abuse-deterrent properties. Pharmacokinetic data demonstrate that, in order to deliver the intended amount of oxycodone, the drug product must be taken with food. The committees will be asked to discuss the potential safety risks and the potential effects on efficacy associated with the extent of the food effect, and potential fluctuations in oxycodone levels that may occur if the product is not taken consistently with the same amount of food. In addition, the committees will be asked to review and discuss whether the data characterizing the abuse-deterrent properties support the likelihood that this drug product will have a meaningful effect on abuse and whether potential benefits to the public from abuse-deterrent properties outweigh potential risks to patients from the effect of food. The committees will be asked to vote on whether this product should be approved for marketing in the United States.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic with DSRM

Meeting Date: 9/10/15-9/10/15

Meeting Details:

The committees will be asked to discuss new drug application (NDA) 206830, oxycodone immediate-release tablets, submitted by Purdue Pharma, with the proposed indication of the management of moderate to severe pain where the use of an opioid analgesic is appropriate. It has been formulated with the intent to provide abuse-deterrent properties. The pharmacokinetic data demonstrate that there is a significant food effect resulting in a significant delay in absorption and peak plasma concentration of oxycodone when taken with food. The applicant proposes to address this finding by labeling the product to be taken on an empty stomach, but patients may have difficulty complying with these instructions as the product is dosed every 4 to 6 hours as needed. The committees will be asked to discuss the potential safety risks and the potential effects on efficacy associated with the delayed peak concentration when taken with food, and the feasibility of labeling to be taken an empty stomach as a means to mitigate the potential risks. The committees will also be asked to consider whether the potential public health benefit of the product’s abuse-deterrent properties are sufficient to outweigh the risk to patients who are prescribed the product for the management of pain.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCancelled: Anesthetic and Analgesic Drug AdComm

Meeting Date: 3/18/15-3/18/15

Meeting Details:

The committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., for the proposed indication of reversal of moderate or deep neuromuscular blockade induced by rocuronium or vecuronium.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drugs AdComm

Meeting Date: 4/22/14-4/22/14

Meeting Details:

The committee will discuss the safety and efficacy for new drug application 203077, MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, QRxPharma Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. This product represents the first drug combination consisting of two immediate-release opioids.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting Options*** Cancelled *** Anesthetic and Analgesic Drug Products AdComm

Meeting Date: 7/17/13-7/18/13

Meeting Details:

The committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., for the proposed indications of routine reversal of moderate and deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium and immediate reversal of NMB at three minutes after administration of rocuronium.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug AdComm

Meeting Date: 12/7/12-12/7/12

Meeting Details:

The committee will discuss the risks and benefits of new drug application (NDA) 202880, by Zogenix Inc., for hydrocodone bitartrate extended-release capsules (proposed tradename ZOHYDRO ER), an opioid analgesic medication for the management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. This formulation of hydrocodone bitartrate extended-release capsules represents the first single-entity (i.e., containing no other active pharmaceutical ingredients, such as acetaminophen or ibuprofen) hydrocodone-containing drug product. It will be formulated in dose strengths up to 50 milligrams, and administered twice daily (i.e., every 12 hours). The committee will be asked to determine whether the benefit-risk assessment of this product favors its approval for marketing.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 2/9/12-2/9/12

Meeting Details:

The committee will discuss the available efficacy and safety data for supplemental new drug application (sNDA) 22395/S–013, QUTENZA (capsaicin 8%) Patch, by NeurogesX, Inc., for the proposed indication of management of neuropathic pain (nerve pain) related to HIV-associated peripheral neuropathy (nerve pain in the periphery of the body, such as the feet and legs).

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs AdComm

Meeting Date: 3/10/11-3/10/11

Meeting Details:

On March 10, 2011, the committee will: (1) Receive updates regarding neurodegenerative findings (findings related to degeneration in the nervous system) in juvenile animals exposed to anesthetic drugs, as well as results from human epidemiological studies using anesthesia in children (information related to studies of patterns and causes of disease); (2) discuss the relevance of these findings to pediatric patients and provide guidance for future preclinical and clinical studies; and (3) discuss the potential implications of these data upon the practice of pediatric anesthesia as well as the communication of the risk of sedative/anesthetic agents to prescribers and parents.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs /DSRM AdComm

Meeting Date: 10/21/10-10/22/10

Meeting Details:

The committee will discuss considerations for the design of postmarketing studies for new drug application (NDA) 22-272 , OxyContin (oxycodone hydrochloride controlled-release) Tablets, Purdue Pharma, Inc. and NDA 22-321 Embeda (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules, Alpharma Pharmaceuticals, LLC and King Pharmaceuticals Research & Development, Inc., approved for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The postmarketing studies are intended to be epidemiological or observational studies that will assess the known serious risks of these products and whether product-specific properties which are intended to deter misuse and abuse actually result in a decrease in the risks of misuse and abuse, and their consequences: addiction, overdose, and death.

 

       
Location: Hilton Washington DC/North Gaithersburg 620 Perry Parkway Gaithersburg, Maryland Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs AdComm

Meeting Date: 8/19/10-8/19/10

Meeting Details:

On August 19, 2010, the committee will discuss the available safety and efficacy data for new drug application (NDA) 22516, CYMBALTA (duloxetine HCL) Capsules, by Eli Lilly and Co., as it relates to the proposed indication of treatment of chronic pain.

 

       
Location: Bethesda Marriott The Ballrooms 5151 Pooks Hill Rd. Bethesda, MD. Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic & Life Support and DSRM AdComm

Meeting Date: 7/22/10-7/23/10

Meeting Details:

The committees will discuss Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting opioid analgesics. As a part of the materials for the meeting, FDA anticipates presenting a proposal for a class-wide opioid REMS and will solicit feedback from the advisory committees and public on the components of that proposal. The need for adequate pain control is an element of good medical practice. In this context, some persons suffering from pain need access to potent opioid drug products; however, inappropriate prescribing, addiction and death due to prescription opioid abuse and misuse have been increasing over the last decade.

 

       
Location: The Marriott Inn and Conference Center, Adelphi, MD. Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support & DSRM AdComm

Meeting Date: 4/22/10-4/22/10

Meeting Details:

The committees will discuss new drug application (NDA) 22-451 ACUROX (oxycodone HCl and niacin) Tablets, Acura Pharmaceuticals, Inc., for the proposed indication of relief of moderate to severe pain where the use of an immediate-release, orally administered, opioid analgesic tablet is appropriate, and the results of studies evaluating the addition of niacin, added for the purpose of reducing the misuse of oxycodone.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs AdComm - Eli Lilly Meeting Cancelled

Meeting Date: 1/28/10-1/28/10

Meeting Details:

On January 28, 2010, the committee will discuss the available safety and efficacy data for new drug application (NDA) 22516, CYMBALTA (duloxetine HCL) Capsules, by Eli Lilly and Co., as they relate to the proposed indication of treatment of chronic pain.

 

       
Location: Hilton Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs/DSRM AdComm

Meeting Date: 9/24/09-9/24/09

Meeting Details:

The committees will discuss new drug application (NDA) 22272, OXYCONTIN (oxycodone hydrochloride controlled-release) Tablets, Purdue Pharma L.P., and its safety for the proposed indication of management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. This formulation was previously reviewed and discussed by these committees on May 5, 2008, and will be considered again in light of new data.

 

       
Location: Holiday Inn Gaithersburg MD Related News Links: Not Available
Time: 9:15AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs/DSRM AdComm

Meeting Date: 9/23/09-9/23/09

Meeting Details:

The committees will discuss new drug application (NDA) 21217, EXALGO (hydromorphone HC1), Neuromed Pharmaceuticals, Inc., a modified-release hydromorphone drug product indicated for the treatment of moderate-to-severe pain in opioid-tolerant patients.

 

       
Location: HOL Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support /DSRM AdComm

Meeting Date: 1/30/09-1/30/09

Meeting Details:

The committee will discuss the available safety and efficacy data for all propoxyphene-containing products (including hydrochloric acid (HCl), napsylate salts, and combination drugs) and whether any regulatory action is appropriate.

 

       
Location: Hilton Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support and DSRM AdCOmm

Meeting Date: 11/13/08-11/14/08

Meeting Details:

On November 13 and 14, 2008, the committees will begin with a closed session, from 8 a.m. to 9:15 a.m. Following the closed session, from 9:15 a.m. to 4:30 p.m., the meeting will be open to the public. On November 13, 2008, the committees will discuss new drug application (NDA) 22324, REMOXY XRT (oxycodone hydrochloride controlled-release) Capsules, Pain Therapeutics Inc., and its safety for the proposed indication of management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled-release characteristics of this formulation are purportedly less easily defeated than other formulations of controlled-release oxycodone. On November 14, 2008, the committees will discuss new drug application NDA 22321, EMBEDA (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules, Alpharma Pharmaceuticals L.L.C., and its safety for the proposed indication of management of moderate to severe chronic pain. The naltrexone component of this formulation is intended to mitigate abuse of the product when attempts are made to defeat the controlled-release properties of the formulation.

 

       
Location: HOL Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs AdComm

Meeting Date: 5/7/08-5/7/08

Meeting Details:

On May 7, 2008, the committee will discuss new drug application (NDA) 22–244, fospropofol disodium injection (35 milligrams/milliliter) (proposed tradename Aquavan), MGI Pharma, Inc., for the proposed indication of sedation in adult patients undergoing diagnostic or therapeutic procedures.

 

       
Location: Holiday Inn - The Ballrooms Two Montgomery Village Avenue Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Anesthetic-Life and DSRM AdComm

Meeting Date: 5/5/08-5/6/08

Meeting Details:

On May 5, 2008, the committees will discuss new drug application (NDA) 22–272, OXYCONTIN (oxycodone hydrochloride controlled-release) Tablets, Purdue Pharma L.P., and its safety for the proposed indication of management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The sustained-release characteristics of this formulation are purportedly less easily defeated than other formulations of OXYCONTIN. On May 6, 2008, the committees will discuss supplemental new drug application (sNDA) 21–947/ s-005, FENTORA (fentanyl buccal tablet), Cephalon, Inc., and its safety for the proposed indication of breakthrough pain in opioid tolerant non-cancer patients with chronic pain.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs AdComm

Meeting Date: 3/11/08-3/11/08

Meeting Details:

The committee will discuss the new drug application [NDA) 22-225, sugammadex sodium injection (proposed tradename BRIDION), Organon USA Inc., for the proposed indication of routine reversal of shallow and profound neuromuscular blockade (NMB) induced by rocuronium or vecuronium and immediate reversal of NMB at three minutes after administration of rocuronium.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs AdComm

Meeting Date: 3/29/07-3/29/07

Meeting Details:

The committee will do the following: (1) Receive presentations regarding neurodegenerative findings in juvenile animals exposed to anesthetic drugs (e.g., ketamine); and (2) discuss the relevance of these findings to pediatric patients and provide guidance for future preclinical and clinical studies.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory Committee

Meeting Date: 11/18/03-11/19/03

Meeting Details:

On November 18, 2003: the committee will discuss the assessment and management of risk related to QTc prolongation by Droperidol (Inapsine) Akorn, Inc., indicated for nausea and vomiting in surgical and diagnostic procedures, premedication, and neuroleptanalgesia.

 

       
Location: Holiday Inn - GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory Committee

Meeting Date: 9/9/03-9/10/03

Meeting Details:

On September 9, 2003, the committee will discuss Risk Management Plans for opiate analgesic drug products with particular attention to modified-release products. On September 10, 2003, the committee will discuss the abuse liability of and Risk Management Plans for Palladone, a modified-release hydromorphone drug product indicated for the treatment of moderate to severe pain in opioid tolerant patients.

 

       
Location: Holiday Inn Bethesda, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs Advisory Committee

Meeting Date: 5/16/02-5/16/02

Meeting Details:

The committee will discuss Specific Issues in development of pharmaceuticals for the treatment of neuropathy and neuropathic pain. Other area's of discussion include Duration of clinical trials, Evaluation of nerve function, Electrophysiological endpoints and general / specific claims.

 

       
Location: Holiday Inn Gaithersburg, Md. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory Committee

Meeting Date: 1/30/02-1/31/02

Meeting Details:

On both days, the committee will discuss the medical use of opiate analgesics in various patient populations, including pediatric patients and patients with chronic pain of nonmalignant etiology, as well as the risk to benefit ratio of extending opiate treatment into these populations. It will also address concerns regarding the abuse potential, diversion and increasing incidence of addiction to opiate analgesics, especially to the modified release opiate analgesics.

 

       
Location: Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory

Meeting Date: 9/13/01-9/14/01

Meeting Details:

On both days, the committee will discuss the medical use of opiate analgesics in various patient populations, including pediatric patients and patients with chronic pain of nonmalignant etiology, as well as the risk to benefit ratio of extending opiate treatment into these populations. It will also address concerns regarding the abuse potential, diversion and increasing incidence of addiction to opiate analgesics, especially to the modified release opiate analgesics.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory

Meeting Date: 6/14/01-6/15/01

Meeting Details:

On both days the committee will discuss the medical use of opiate analgesics in various patient populations, including pediatric patients and patients with chronic pain of nonmalignant etiology, as well as the risk to benefit ratio of extending opiate treatment into these populations. It will also address concerns regarding the abuse potential, diversion and increasing incidence of addiction to opiate analgesics, especially to the modified release opiate analgesics.

 

       
Location: Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs

Meeting Date: 1/12/99-1/12/99

Meeting Details:

The committee will hear presentations and discuss the cardiovascular safety data submitted regarding new drug application (NDA) 20-997, Chirocaine (levobupivacaine injection), Darwin Discovery Ltd., a local anesthetic agent indicated for surgical anesthesia and pain management.

 

       
Location: FDA Building Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs

Meeting Date: 2/5/98-2/5/98

Meeting Details:

Organon Inc. - Orgaran (danaparioid sodium) Injection Pharmacia & Upjohn - Prevention of Perioperative Thromboembolic Complications with Low Molecular Weight Heparins in Patients Receiving Epidural/Spinal Anesthesia: Risk/Benefit Considerations - Experience with Fragmin Rhone-Polenc Rorer - Lovenox (enoxaparin sodium) Injection Wyeth Laboratories - Normiflo (adreparin sodium) Injection

 

       
Location: Holiday Inn Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory Committee

Meeting Date: 9/17/97-9/17/97

Meeting Details:

The committee will hear presentations and discuss data submitted regarding new drug application (NDA) 20-747, ActiqTM (oral transmucosal fentanyl citrate, drug matrix on a handle), Anesta Corp., for the management of chronic pain, particularly breakthrough pain, in patients who are already receiving and are tolerant to opioid therapy.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory Committee

Meeting Date: 12/18/96-12/18/96

Meeting Details:

The committee will discuss labeling for NDA 18-654, Versed (midazolam HC1), Hoffmann La-Roche, for pediatric sedation.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory Committee

Meeting Date: 4/29/96-4/30/96

Meeting Details:

The committee will discuss the new drug application (NDA) 20-630, Remifentanyl, Glaxo Welcome, for use as a general anesthetic, and a report of the post-market experience and phase IV commitments of NDA 20-478, Ultane (sevoflurane), Abbott Laboratories.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs Advisory Committee

Meeting Date: 12/11/95-12/12/95

Meeting Details:

The committee will discuss the new drug application (NDA) 20-533, Naropin , Astra Laboratories, for use as a local anesthetic and a report of the postmarket surveillance of NDA 27-428, Oralet, Anesta.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs

Meeting Date: 1/17/95-1/17/95

Meeting Details:

Sevorane

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs

Meeting Date: 6/9/94-6/9/94

Meeting Details:

On June 9, 1994, the committee will discuss: (1) The labeling of succinylcholine chloride injection (neuromuscular blocking agent) new drug applications (NDA's) 8-453, Burroughs Wellcome and Co.; 8-845, Abbott Laboratories; 8-847, Bristol- Myers Squibb Co.; and 80-997, Organon, Inc.; and (2) adverse experience associated with the administration of 5 percent lidocaine for spinal anesthesia, NDA 20-098/S-04, Astra Pharmaceutical Products, Inc. On June 10, 1994, the committee will hear a progress report on the metabolism of lidocaine by human liver tissues.

 

       
Location: FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 5/5/16-5/5/16

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Meeting Details:

The committees will be asked to discuss new drug application (NDA) 208653, benzhydrocodone/acetaminophen oral tablets, submitted by KemPharm, Inc., with the proposed indication of short-term (up to 14 days) management of acute pain. The product has been formulated with the intent to provide abuse-deterrent properties. Benzhydrocodone is a hydrocodone prodrug which, according to the applicant, is rapidly converted into hydrocodone by enzymes in the gastrointestinal tract. The active drugs in this fixed-dose combination are hydrocodone and acetaminophen. The applicant has submitted data to support abuse-deterrent properties for this product. The committees will be asked to discuss whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, and whether the nasal route of abuse is relevant for combination products made up of hydrocodone and acetaminophen.

 

       
Location: tbd Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/24/16-5/25/16

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Meeting Details:

On May 24th - The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed indication: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus. On May 25th - The committee will discuss the safety and efficacy of new drug applications (NDAs) 208673 for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services Inc., proposed for the treatment of adults with type 2 diabetes mellitus.

 

       
Location: TBD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 5/24/16-5/24/16

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Meeting Details:

On May 24, 2016, the committee will discuss, make recommendations and vote on information related to the premarket approval application regarding St. Jude Medical's AMPLATZER Patent Foramen Ovale (PFO) Occluder. The AMPLATZER PFO Occluder is a percutaneously delivered permanent cardiac implant for PFO closure. The device is indicated for preventing recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

 

       
Location: Hiton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/24/16-5/25/16

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Meeting Details:

On May 24th - The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed indication: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus. On May 25th - The committee will discuss the safety and efficacy of new drug applications (NDAs) 208673 for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services Inc., proposed for the treatment of adults with type 2 diabetes mellitus.

 

       
Location: TBD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 6/2/16-6/3/16

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Meeting Details:

On June 2 and 3, 2016, the committee will discuss recent reports and epidemiologic investigations of nontuberculous mycobacteria (NTM) infections associated with the use of heater-cooler devices during cardiac surgical procedures. FDA is convening this committee to seek expert scientific and clinical opinion related to contamination of heater-cooler devices, associated patient infections, and mitigation strategies based on available scientific information. The committee will make recommendations on: (1) the effectiveness of cleaning and disinfection methods for heater-cooler devices; (2) the amount and type of premarket data and information needed to demonstrate validation of cleaning and disinfection of heater-cooler devices in support of labeling claims and technical instructions; 5 (3) appropriate risk mitigations to be implemented by manufacturers of heater-cooler devices and/or hospital facilities to ensure patient safety during surgical procedures where these devices are used; and (4) appropriate guidelines and/or criteria based on a risk stratification schema for notifying patients who may have already been exposed to NTM during prior cardiac surgeries. Recommendations on these issues will assist FDA in minimizing patient exposure to infections that may result from contaminated heater-cooler devices.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 6/7/16-6/7/16

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Meeting Details:

The committees will be asked to discuss new drug application (NDA) 207975, hydrocodone bitartrate extended-release tablets, submitted by Teva Branded Pharmaceutical Products R&D, Inc., with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an extended-release formulation intended to have abusedeterrent properties based on its physicochemical properties. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

 

       
Location: TBD Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 6/8/16-6/8/16

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Meeting Details:

The committees will be asked to discuss new drug application (NDA) 207621, oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules, submitted by Pfizer, Inc., with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an extended-release formulation intended to have abuse-deterrent properties based on the presence of naltrexone, an opioid antagonist, in the formulation. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

 

       
Location: TBD Related News Links: Not Available
Time: 8:00AM-2:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting-Anesthetic and Analgesic Drug Products AC, the DSRM AC, and the Pediatric AC

Meeting Date: 9/15/16-9/16/16

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Meeting Details:

The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation.

 

       
Location: TBD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Advisory Committee

Meeting Date: 4/25/16-4/25/16

Meeting Details:

The committee will discuss new drug application (NDA) 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

 

       
Location: College Park Marriott Hotel and Conference Center Chesapeake Ballroom 3501 University Boulevard East, Hyattsville, MD 20783 Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel of the Medical Devices AdComm

Meeting Date: 4/20/16-4/20/16

Meeting Details:

The Committee will discuss, make recommendations, and vote on the premarket approval application for the Cartiva Synthetic Cartilage Implant (SCI), sponsored by Cartiva, Inc. The Cartiva Synthetic Cartilage Implant (SCI) is an organic polymer-based biomaterial to mimic biologic cartilage. The device is to be indicated for treatment of degenerative and post-traumatic arthritis in the first metatarsophalangeal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsophalangeal joint.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee Meeting

Meeting Date: 4/15/16-4/15/16

Meeting Details:

The committee will discuss data submitted by Galderma Laboratories, L.P. to support supplemental new drug application (sNDA) 20-380, for over-the-counter (OTC) marketing of adapalene gel 0.1%. The proposed OTC use is for the treatment of acne and to clear up acne pimples and acne blemishes. The applicant proposes to label the product for 12 years and older. The committee will be asked to consider whether data support an acceptable risk/benefit profile for the nonprescription use of adapalene gel 0.1% by OTC consumers.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 4/12/16-4/12/16

Meeting Details:

On April 12, 2016, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155). See the list of the products in this document to be discussed. In addition, FDA will be providing information on a proposed public advisory committee meeting for September 15 and 16, 2016, on appropriate pediatric development plans for prescription opioid drugs. Prior to the safety reviews and the open public hearing (see later in this section for further information), FDA will present, from approximately 8:30 to 9:30 a.m., a framework of current plans for a 2-day joint meeting of the PAC, the Anesthetic and Analgesic Drug Products Advisory Committee, and the Drug Safety and Risk Management Advisory Committees. Elsewhere in this issue of the Federal Register, FDA is publishing an announcement of this advisory committee meeting to be held on September 15 and 16, 2016, on the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Following the presentation on the proposed framework for the September meeting, there will be an hour of open public hearing from 9:30 a.m. to 10:30 a.m. to provide an opportunity for the public to provide input concerning the topics before the PAC, including the use of opioids for control of severe pain in the pediatric population. To assist with the planning of this advisory committee meeting, FDA is establishing a public docket [Docket No. FDA-2016-N-0584] to receive input on appropriate pediatric development plans for prescription opioid drugs. The docket will remain open following the September advisory committee meeting. Comments about the upcoming September advisory committee meeting should not be submitted to the docket number listed at the top of this Federal Register notice [Docket No. FDA-2016-N-0567]. Please also see the ADDRESSES section of this notice for further docket information. The pediatric-focused safety reviews for the Centers will then occur. The PAC will meet to discuss the following products (listed by FDA Center): Center for Biologics Evaluation and Research (CBER): [cir] FLULAVAL QUADRIVALENT (influenza virus vaccine) [cir] FLULAVAL TRIVALENT (influenza virus vaccine) [cir] FLUZONE QUADRIVALENT (influenza virus vaccine) Center for Drug Evaluation and Research (CDER): [cir] ACIPHEX SPRINKLES (rabeprazole sodium) [cir] SKYLA (levonorgestrel-releasing intrauterine system) [cir] MYCAMINE (micafungin sodium) [cir] NOXAFIL (posaconazole) [cir] PRECEDEX (dexmedetomidine hydrocholoride) [cir] SABRIL (vigabatrim) [cir] SEROQUEL (quetiapine fumarate) and SEROQUEL XR (quetiapine fumarate extended-release) [[Page 8509]] [cir] SKYLA (levonorgestrel-releasing intrauterine system) [cir] SYMBAX (fluoxetine hydrocholoride and olanzapine) [cir] VYVANSE CAPSULES (lisdexamfetamine dimesylate) [cir] XELODA (capecitabine) Center for Devices and Radiological Health (CDRH): [cir] IMPELLA RP SYSTEM (humanitarian use device (HUD)) [cir] LIPSORBER LA-15 SYSTEM (HUD) [cir] MEDTRONIC ACTIVA DYSTONIA THERAPY (HUD) In addition to the agenda items, the PAC will remain in public session over the lunch hour on April 12, 2016, to hear a presentation and provide feedback on an FDA proposal for a risk-based approach to the pediatric-focused safety reviews mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The working lunch currently is scheduled between approximately 12:30 p.m. and 1:15 p.m.

 

       
Location: DoubleTree Bethesda 8120 Wisconsin Avenue Bethesda, MD 20814 Related News Links: Not Available
Time: 8:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee Meeting

Meeting Date: 4/12/16-4/12/16

Meeting Details:

The committee will discuss new drug application (NDA) 208542 rociletinib tablets, application submitted by Clovis Oncology, Inc. The proposed indication (use) for this product is for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test.

 

       
Location: TBD Related News Links: Not Available
Time: 8:30AM-1:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 4/7/16-4/7/16

Meeting Details:

The committee will discuss new drug application (NDA) 207999, obeticholic acid oral tablets, submitted by Intercept Pharmaceuticals, Inc., proposed for the treatment of primary biliary cirrhosis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

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