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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

Meeting Details:

The committee will hear presentations and discuss data submitted regarding new drug application (NDA) 20-747, Actiq^TM (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.

Meeting Details:

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

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.

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.

Meeting Details:

Sevorane

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.

Meeting Details:

The committee will discuss the abuse potential of the drug dextromethorphan and the public health benefits and risks of dextromethorphan use as a cough suppressant in prescription and nonprescription drug products. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for dextromethorphan in response to the increased incidence of abuse, especially among adolescents.

Meeting Details:

On September 15, 2010, the committee will discuss the results of the Sibutramine Cardiovascular Outcomes Trial (SCOUT) (M01392), for new drug application (NDA) 20632, MERIDIA (sibutramine hydrochloride monohydrate) Capsules, sponsored by Abbott Laboratories, for treatment of obesity. The SCOUT study was a randomized, double-blind, placebo-controlled trial, which is a kind of clinical trial designed to provide data with strong measures of accuracy and reliability. The SCOUT trial evaluated the potential benefits of weight loss with MERIDIA on major cardiovascular (heart and blood circulation) adverse events. The preliminary results of the SCOUT trial indicated that clinical trial participants who received MERIDIA instead of placebo (no active drug) had a higher incidence of major cardiovascular adverse events that was statistically significant. On September 16, 2010, the committee will discuss the safety and efficacy of new drug application (NDA) 22529, with the proposed trade name LORQESS (lorcaserin hydrochloride) Tablets, sponsored by Arena Pharmaceuticals, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) of equal to or greater than 30 kilograms (kg) per square meter, or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related co-morbidities (which include, for example: High blood pressure, heart disease, or diabetes). The BMI is a measure of body weight (mass) based on a person's weight and height, and is a widely-used tool for doctors in assessing optimum weights for a patient.

Meeting Details:

The committee will discuss the available safety and efficacy data for supplemental new drug application (sNDA) 21897/015, VIVITROL (naltrexone for extended-release injectable suspension), sponsored by Alkermes, Inc., for the treatment of opioid dependence.

Meeting Details:

The committee will discuss new drug application (NDA) 22512, dabigatran etexilate mesylate capsules, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed indication of prevention of stroke in patients with atrial fibrillation (abnormally rapid contractions of the atria, the upper chambers of the heart).

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical development of aerosolized antimicrobials for the management and/or treatment of patients with cystic fibrosis. Aerosolized antimicrobials are used to treat chronic bacterial infection in the lungs and thus improve the respiratory symptoms in patients with cystic fibrosis. This public workshop is intended to provide information for and gain perspective from health care providers, patients and patient advocacy organizations, academia, and industry on various aspects of the design of clinical trials of aerosolized antimicrobials in patients with cystic fibrosis. The input from this public workshop will help in developing topics for further discussion.

Meeting Details:

On August 26, 2010, the committee will discuss, make recommendations, and vote on premarket approval application for MelaFind, sponsored by MELA Sciences, Inc. MelaFind is a non-invasive computer vision system intended to assist in the evaluation of pigmented skin lesions, including atypical moles, which have one or more clinical or historical characteristics of melanoma, before a final decision to biopsy has been rendered. MelaFind acquires and displays multi-spectral (from blue to near infrared) digital images of pigmented skin lesions and uses automatic image analysis and statistical pattern recognition to help identify lesions to be considered for biopsy to rule out melanoma.

Meeting Details:

On September 7, 2010, the committee will discuss new drug application (NDA) 200327, for ceftaroline fosamil for injection, suOn September 7, 2010, the committee will discuss new drug application (NDA) 200327, for ceftaroline fosamil for injection, submitted by Cerexa, Inc., and the requested indications of: (1) Treatment of adults with community acquired bacterial pneumonia (CABP); and (2) complicated skin and skin structure infections (cSSSI). The morning session will be devoted to discussing the CABP indication, and the afternoon session to discussing the cSSSI indication.bmitted by Cerexa, Inc., and the requested indications of: (1) Treatment of adults with community acquired bacterial pneumonia (CABP); and (2) complicated skin and skin structure infections (cSSSI). The morning session will be devoted to discussing the CABP indication, and the afternoon session to discussing the cSSSI indication.

Meeting Details:

On August 20, 2010, the committees will discuss new drug application (NDA) 22-531, sodium oxybate, 375 milligrams per milliliter (mg/ml) oral solution, sponsored by Jazz Pharmaceuticals, with a proposed indication for the treatment of fibromyalgia for patients 18 years of age and older . The safety and efficacy findings for sodium oxybate in the fibromyalgia population and the proposed Risk Evaluation and Mitigation Strategy (REMS) for this product will be discussed.

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.

Meeting Details:

On August 11, 2010, the committee will discuss new drug application (NDA) 22-345, with the proposed trade name POTIGA (ezogabine) Tablets, by Valeant Pharmaceuticals North America. The proposed indication for this new drug product is adjunctive therapy in patients with partial-onset seizures.