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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse Advisory Committee

Meeting Date: 4/20/99-4/20/99

Meeting Details:

The committee will be discussing appropriate patient populations and outcome measures for clinical trials for drugs to treat alcohol use disorders. On April 20, 1999, from 1:30 p.m. to 4 p.m., the committee will hear trade secret and/or confidential information relevant to pending investigational new drugs (INDs). This portion of the meeting will be closed to permit discussion of this information.

 

       
Location: CDER/Advisory Committee Conference Room 5630 Fish Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse Advisory Committee

Meeting Date: 4/27/98-4/28/98

Meeting Details:

The scientific evidence for initiating a scheduling action for ULTRAM(R) (tramadol hydrochloride), R.W. Johnson Pharmaceutical Research Institute, under the Controlled Substance Act.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse

Meeting Date: 6/9/97-6/10/97

Meeting Details:

The committee discussed the labeling of smoking cessation products.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse Advisory Committee

Meeting Date: 2/10/97-2/11/97

Meeting Details:

On February 10, 1997, the committee will discuss Quit TM Brand silver acetate lozenges, New Life Health Products, for smoking cessation. On February 11, 1997, the committee will discuss new drug application (NDA) 11-792, Soma (carisoprodol generic tablets, Wallace Laboratory), for muscle relaxation and generic drugs containing carisoprodol. The committee will consider a Drug Enforcement Administration petition regarding scheduling of carisoprodol under the Controlled Substances Act.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse Advisory Committee

Meeting Date: 12/12/96-12/13/96

Meeting Details:

Wellbutrin SR for smoking cessation Nicotrol nicotine inhaler for smoking cessation

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse Advisory Committee

Meeting Date: 9/29/95-9/29/95

Meeting Details:

The Nonprescription Drugs Advisory Committee reviews and evaluates data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products for use in the treatment of a broad spectrum of human symptoms and diseases. The Endocrinologic and Metabolic Drugs Advisory Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in endocrine and metabolic disorders. The Drug Abuse Advisory Committee advises on the scientific and medical evaluation of information gathered by the Department of Health and Human Services and the Department of Justice on the safety, efficacy, and abuse potential of drugs and recommends actions to be taken on the marketing, investigation, and control of such drugs. The Gastrointestinal Drugs Advisory Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in gastrointestinal diseases.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Drug Abuse

Meeting Date: 9/28/95-9/28/95

Meeting Details:

Nonprescription Drugs Advisory Committee and the Drug Abuse Advisory Committee will discuss data relevant to NDA 20-066 (Nicorette 4 milligrams (mg) and NDA 18-612 (Nicorette 2 mg) to switch nicotine polacrilex (Nicorette, SmithKline Beecham Consumer Healthcare Products) from prescription to over-the-counter status for use as an aid to smoking cessation for the relief of nicotine withdrawal symptoms.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse

Meeting Date: 4/7/95-4/7/95

Meeting Details:

On April 7, 1995, the committee will discuss the 1995 Institute of Medicine Report on the Development of Medications for the Treatment of Opiate and Cocaine Addiction.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDrug Abuse

Meeting Date: 8/1/94-8/3/94

Meeting Details:

N/A

 

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

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Upcoming Meetings

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 1/16/20-1/16/20

Meeting Details:

The committee will discuss new drug application (NDA) 204803, bupivacaine extended-release solution for instillation, submitted by DURECT Corp., for the proposed indication of post-surgical analgesia. The committee will discuss whether the Applicant adequately demonstrated the safety and efficacy of bupivacaine extended-release solution for post-surgical analgesia and the appropriateness of the proposed patient populations. The committee will also be asked to discuss the approvability of this product.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products and DSRM AdComm

Meeting Date: 1/15/20-1/15/20

Meeting Details:

During the morning session, the committees will discuss new drug application (NDA) 213426, for tramadol 44 milligrams (mg) and celecoxib 56 mg tablet, which contains a fixed-dose combination of an opioid and a non-steroid anti-inflammatory drug, submitted by Esteve Pharmaceuticals, S.A., for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees will be asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.

During the afternoon session, the committees will discuss NDA 209653, for an extended-release oral tablet formulation of oxycodone, submitted by Intellipharmaceutics Corp., with the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these 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, as well as to discuss the overall risk-benefit profile of the product.

 

       
Location: White Oak Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products and DSRM AdComm

Meeting Date: 1/14/20-1/14/20

Meeting Details:

The committees will discuss new drug application 211802 for oxycodegol, a new molecular entity full mu-opioid receptor agonist, submitted by Nektar Therapeutics, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees will be asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.

 

       
Location: 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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