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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding

Meeting Date: 7/13/00-7/14/00

Meeting Details:

On July 13, 2000, the committee will review five drug products for inclusion on a list of drug products that cannot be compounded because they have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective whereby FDA amended its regulations to include such a list of drug products). In the Federal Register of January 4, 2000 (65 FR 256), FDA published a proposed rule amending these regulations to add two drug products to the list: (1) Aminopyrine (all drug products containing aminopyrine) and (2) astemizole (all drug products containing astemizole). In addition to these two drug products, the committee will review the following three drug products: (1) Grepafloxacin (all drug products containing grepafloxacin), (2) troglitazone (all drug products containing troglitazone), and (3) cisapride (all drug products containing cisapride). Beginning at approximately 10 a.m., and continuing on July 14, 2000, at approximately 8:30 a.m., the committee will discuss and provide FDA with advice about drug products that present demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of those drug products.

 

       
Location: FDA Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding

Meeting Date: 5/6/99-5/7/99

Meeting Details:

The committee will discuss and provide FDA with advice about the agency's development and publication of a list of bulk drug substances that may be used in pharmacy compounding that do not have a United States Pharmacopeia or National Formulary monograph and are not components of FDA-approved drugs. Specifically, the committee is likely to address the following drug substances as candidates for the bulk drugs list: 4-aminopyridine, 3,4-diaminopyridine, betahistine dihydrochloride, chloramine-T, cyclandelate, dinitrochlorobenzene, diphenylcyclopropenone, hydrazine sulfate, mild silver protein, monosodium asparate, pentylenetetrazole, peruvian balsam, and squaric acid dibutyl ester.

 

       
Location: CDER Advisory Committee Conference Room 1066 56 Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding

Meeting Date: 10/14/98-10/16/98

Meeting Details:

The Committee will address those bulk drug substances that are neither components of FDA approved products nor covered by a USP monograph for inclusion on a list of bulk drug substances that may be used in compounding that qualifies for the applicable statutory exemptions. The Committee will also review drug products to be included on a list which have been withdrawn or removed from the market for reasons of safety or efficacy which may not be used in compounding that qualifies for the applicable statutory exemptions.

 

       
Location: Food and Drug Administration Building Rockville, Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Upcoming Meetings

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

Meeting Date: 7/7/15-7/8/15

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Meeting Details:

The committees will discuss the results of post marketing studies evaluating the misuse and/or abuse of reformulated OXYCONTIN (oxycodone hydrochloride) extended-release tablets, supplemental new drug application (sNDA) 022272, manufactured by Purdue Pharma L.P. The committees will discuss whether these studies have demonstrated that the reformulated OXYCONTIN product has had a meaningful impact on abuse of OXYCONTIN.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 7/9/15-7/9/15

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Meeting Details:

The committee will discuss biologics license application 125547, necitumumab injection, application submitted by Eli Lilly and Company. The proposed indication (use) for this product is in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Adcomm

Meeting Date: 6/11/15-6/11/15

Meeting Details:

The committee will discuss biologics license application (BLA) 125526, for mepolizumab for injection, submitted by GlaxoSmithKline for the proposed indication of add-on maintenance treatment in patients 12 years and older with severe eosinophilic asthma identified by blood eosinophils greater than or equal to 150 cells/microliter at initiation of treatment or blood eosinophils greater than or equal to 300 cells/microliter in the past 12 months

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAmgen REPATHA - Endocrinologic & Metabolic Drugs AdComm

Meeting Date: 6/10/15-6/10/15

Meeting Details:

The committee will discuss the safety and efficacy of biologics license application (BLA) 125522, proposed trade name REPATHA (established name: Evolocumab) for injection, submitted by Amgen Inc., as adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (ApoB), non-high-density lipoprotein cholesterol (non-HDL-C), TC/HDL-C, ApoB/ApoA1, very low-density lipoprotein cholesterol, triglyceride, and lipoprotein A, and to increase HDL-C and ApoA1, in adults with hyperlipidemia or mixed dyslipidemia, either in combination with a statin or statin with other lipid-lowering therapies (e.g., ezetimibe), or alone, or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or alone or in combination with other lipidlowering therapies in patients for whom a statin is not considered clinically appropriate. In addition, the committee will discuss the safety and efficacy of evolocumab to reduce LDL-C, TC, ApoB, and non-HDL-C, in combination with other lipid-lowering therapies (e.g. statins, LDL apheresis) in patients at least 12 years of age with homozygous familial hypercholesterolemia.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsSanofi Aventis PRALUENT - Endocrinologic & Metabolic Drugs AdComm

Meeting Date: 6/9/15-6/9/15

Meeting Details:

The committee will discuss the safety and efficacy of biologics license application 125559, proposed trade name PRALUENT (established name: Alirocumab) for injection, submitted by Sanofi Aventis, U.S., as an adjunct to diet, for long-term treatment of adult patients with primary hypercholesterolemia (non-familial and heterozygous familial) or mixed dyslipidemia including patients with type 2 diabetes mellitus, to reduce low-density lipoprotein cholesterol, total cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein B, tryglyceride, and lipoprotein A, and to increase high-density lipoprotein cholesterol and apolipoprotein A-1 either in combination with a statin or as monotherapy including in patients who cannot tolerate statins.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm

Meeting Date: 6/4/15-6/4/15

Meeting Details:

The committees will discuss new drug application (NDA) 022526, flibanserin 100 milligram (mg) tablets, submitted by Sprout Pharmaceuticals Inc., proposed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 7:30AM-5:30PM    
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Past Meetings

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