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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPostPoned: Arthritis AdComm

Meeting Date: 3/17/15-3/17/15

Meeting Details:

The committee will discuss biologics license application (BLA) 125544 for CTP13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy;(2) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease; (3) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (4) reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; (5) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy;1 (6) in combination with methotrexate, reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis; (7) reducing signs and symptoms in patients with active ankylosing spondylitis; (8) reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis; and (9) treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis & DSRM AdComm

Meeting Date: 2/10/14-2/11/14

Meeting Details:

The committees will discuss data and analyses published in 2006 or later that are relevant to further understanding the relationship between nonsteroidal anti-inflammatory drugs (NSAIDs) and cardiovascular thrombotic risk that is currently described in NSAID class labeling.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs AdComm

Meeting Date: 7/22/13-7/23/13

Meeting Details:

On July 22, 2013, the committee will discuss the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis and the implications of using these criteria for drug approval. On July 23, 2013, during the morning session, the committee will discuss supplemental biologics license application (sBLA) 125057, HUMIRA (adalimumab) injection, by AbbVie Inc., for the proposed indication of reducing signs and symptoms in adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation by elevated C-reactive protein or magnetic resonance imaging, who have had an inadequate response to, or are intolerant to, a nonsteroidal anti-inflammatory drug. During the afternoon session, the committee will discuss sBLA 125160, certolizumab injection, by UCB, Inc., for the proposed indication of treatment of adult patients with active axial spondyloarthritis, including patients with ankylosing spondylitis.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs AdComm

Meeting Date: 12/20/12-12/20/12

Meeting Details:

The committee will discuss new drug application (NDA) 22151, rintatolimod injection (proposed trade name AMPLIGEN), submitted by Hemispherx Biopharma, Inc., for the treatment of patients with chronic fatigue syndrome.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee;

Meeting Date: 5/9/12-5/9/12

Meeting Details:

The committee will discuss new drug application (NDA) 203214, tofacitinib tablets, Pfizer Inc., for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 5/8/12-5/8/12

Meeting Details:

The committee will discuss supplemental biologics license application 125249, ARCALYST (rilonacept) injection, Regeneron Pharmaceuticals, Inc., for the following proposed indication: "ARCALYST (rilonacept) is an interleukin-1 blocker indicated for the prevention of gout flares during initiation of uric-acid lowering therapy in adult patients with gout. ARCALYST has not been studied for longer than 16 weeks in this clinical setting.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs AdComm

Meeting Date: 3/12/12-3/12/12

Meeting Details:

The committee will discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development and the safety issues possibly related to these drugs. These drugs are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. The committee will be asked to determine whether reports of joint destruction represent a safety signal related to the Anti-NGF class of drugs, and whether the risk benefit balance for these drugs favors continued development of the drugs as analgesics.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPostponed for a Later Date - Arthritis Advisory Committee

Meeting Date: 9/13/11-9/13/11

Meeting Details:

On September 13, 2011, the committee will discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development and the safety issues possibly related to these drugs. These drugs are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. The committee will be asked to determine whether reports of joint destruction represent a safety signal related to the Anti-NGF class of drugs, and whether the risk benefit balance for these drugs favors continued development of the drugs as analgesics.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsILARIS by Novartis - Arthritis AdComm

Meeting Date: 6/21/11-6/21/11

Meeting Details:

On June 21, 2011, the committee will discuss supplemental biologics license application (sBLA) 125319, ILARIS (canakinumab), Novartis Pharmaceuticals Corporation, for the following proposed indication: "ILARIS is indicated for the treatment of gouty arthritis attacks. ILARIS has also been shown to extend the time to the next attack and reduce the frequency of subsequent attacks."

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 11/16/10-11/16/10

Meeting Details:

The committee will discuss biologic license application (BLA) 125370, belimumab, proposed trade name BENLYSTA, sponsored by Human Genome Sciences, for the proposed indication of reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee and DSRM AdComm

Meeting Date: 8/20/10-8/20/10

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.

 

       
Location: Marriott - Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs and DSRM AdComm

Meeting Date: 5/12/10-5/12/10

Meeting Details:

On May 12, 2010, the committees will discuss new drug application (NDA) 22-478, naproxcinod0 375 milligram capsule, sponsored by NicOx S.A., a non-steroidal anti-inflammatory drug (NSAID) product indicated for the treatment of the signs and symptoms of osteoarthritis.

 

       
Location: Hilton Silver Spring MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs AdComm

Meeting Date: 9/16/09-9/16/09

Meeting Details:

The committee will discuss biologics license application (BLA) 12-5338, clostridial collagenase, Auxilium Pharmaceuticals, Inc., for the proposed treatment of advanced Dupuytren's disease. Dupuytren's disease is a condition in which the tendons of the hand that help move the fingers of the hand become thickened and scarred.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 6/16/09-6/16/09

Meeting Details:

The committee will discuss biologics license application (BLA) 125293, KRYSTEXXA (pegloticase), Savient Pharmaceuticals, Inc., as a therapy for patients with refractory gout.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPostponed: Arthritis AdComm

Meeting Date: 3/5/09-3/5/09

Meeting Details:

The committee will discuss biologics license application (BLA) 125293, pegloticase, Savient Pharmaceuticals, Inc., as a therapy for patients with treatment failure gout.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 11/24/08-11/24/08

Meeting Details:

The committee will discuss new drug application (NDA) 21856, ULORIC (febuxostat), Takeda Pharmaceuticals North America, Inc., for the proposed treatment of hyperuricemia in patients with gout.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs AdComm

Meeting Date: 7/29/08-7/29/08

Meeting Details:

The committee will discuss biologics license application (BLA) 125276, ACTEMRA (tocilizumab), Hoffman-La Roche, Inc., for the proposed treatment of adult patients with moderately to severely active rheumatoid arthritis.

 

       
Location: Hilton Washington DC/Silver Spring The Ballrooms 8727 Colesville Road Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-3:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 4/12/07-4/12/07

Meeting Details:

Agenda: The committee will discuss new drug application (NDA) 21-3891 21-772, ARCOXIA (etoricoxib), Merck & Co., Inc., proposed treatment for the relief of signs and symptoms of osteoarthritis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 11/29/06-11/29/06

Meeting Details:

The committee will discuss the safety and efficacy of the nonsteriodal anti-inflammatory drug (COX-2 inhibitor) new drug application (NDA) 20-998/S021, CELEBREX (celecoxib), Pfizer, Inc., for the proposed indication of the relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years and older.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs AdComm

Meeting Date: 9/6/05-9/6/05

Meeting Details:

The committee will discuss biologics license application (BLA) 125118/0, proposed trade name ORENCIA (abatacept), Bristol Myers Squibb, proposed indication for the treatment of moderately to severely active rheumatoid arthritis.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCox-2 Joint Arthritis & Drug Safety Advisory Committee

Meeting Date: 2/16/05-2/18/05

Meeting Details:

The committees will discuss the overall benefit to risk considerations (including cardiovascular and gastrointestinal safety concerns) for COX-2 selective nonsteroidal anti-inflammatory drugs and related agents. FDA is collecting and will be analyzing all available information from the most recent studies of Vioxx, Celebrex, Bextra, and naproxen, and other data for COX-2 selective and nonselective NSAID products to determine whether additional regulatory action is needed. An advisory committee meeting is planned for February 2005, which will provide for a full public discussion of these issues. Related Link From FDA

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 6/2/04-6/3/04

Meeting Details:

On June 2, 2004, the committee will discuss trial design and endpoints for drugs for chronic gout, including new drug application (NDA) 21-740, oxypurinol (proposed tradename, OXIPRIM), Cardiome. On June 3, 2004, the committee will discuss trial design and endpoints for drugs for acute gout, including NDA 21-389, etoricoxib (proposed tradename, ARCOXIA), Merck.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 9/29/03-9/30/03

Meeting Details:

On Both Days, the committee will discuss the purposed the systemic lupus arysmostos sle concept paper a prelimary discussion for creating a guidance document for the development of drugs biologics and devices for the treatment of SLE. On Sept 29 the committee will discuss the proposed sections regarding the current state of the art the claims for treatment and for clinical markers. On Sept 30 the committee will discuss the proposed section concerning trial design.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 6/23/03-6/24/03

Meeting Details:

On June 23, 2003, the committee will discuss fibromyalgia, clinical trial design, including important disease endpoints, in the study and development of therapies and treatments. On June 24, 2003, the committee will discuss the safety and efficacy of submission tracking number (STN) 103795/5123, Enbrel™ (etanercept), Immunex, for reducing signs and symptoms of active ankylosing spondylitis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 3/4/03-3/5/03

Meeting Details:

On March 4, 2003, the committee will hear a safety update on tnf alpha inhibitors; Humira (adalimumab), Abbott Laboratories; Remicade (infliximab) Centocor; and Enbrel (etanercept), Immunex. On March 5, 2003, the committee will discuss the approved product new drug application (NDA) 20-905, ARAVA, (leflunomide), Aventis Pharmaceuticals Inc., clinical data regarding efficacy for improvement in physical function in rheumatoid arthritis, as well as a safety update.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 7/29/02-7/30/02

Meeting Details:

On both days, the committee will discuss the clinical relevance of different classifications of pain as well as discussion of appropriate clinical trial models and designs for medications which would be indicated for each classification of pain.

 

       
Location: Holiday Inn - Bethesda Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 8/16/01-8/17/01

Meeting Details:

On August 16, the committee will discuss the efficacy and safety of submission tracking number (STN) 103950 Kineret (anakinra), Amgen, Inc., for reduction in signs and symptoms of active rheumatoid arthritis. On August 17, the committee will discuss safety update for Enbrel (etanercept), Immunex, and Remicade (infliximab), Centocor, for the treatment of rheumatoid arthritis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 4/19/01-4/19/01

Meeting Details:

On April 19, 2001, the committee will discuss new drug application (NDA) 21-239, Aslera (prasterone, Genelabs Technologies, Inc.) for improvement in disease activity and/or its symptoms in women with mild to moderate systemic lupus erythematosus (SLE) and reduction of corticosteroid requirements in women with mild to moderate SLE.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 2/7/01-2/9/01

Meeting Details:

On February 7, 2001, the committee will discuss new drug application (NDA) 20-998/S009, Celebrex (celecoxib, G. D. Searle & Co.) approved for the treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis in adults. The discussion is for modification of the label based on the results of the CLASS Trial, a study of the incidence of significant upper gastrointestinal effects. On February 8, 2001, the committee will discuss NDA 21-042/S007, VioxxTM (rofecoxib, Merck Research Laboratories) approved for the treatment of signs and symptoms of osteoarthritis and the management of acute pain. The discussion is for changes in the product label related to results of the VIGOR Trial concerning clinical gastrointestinal events. On February 9, 2001, the committee will discuss NDA 20-905/S006, AravaTM (leflunomide, Aventis) approved for the treatment of active rheumatoid arthritis. The discussion is for an indication to prevent disability as evidenced by improved physical function.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 7/12/00-7/12/00

Meeting Details:

The Committee will discuss biologics license application (BLA) 99-1234, Remicade TM (infliximab, Centocor) for the treatment of rheumatoid arthritis, prevention of radiographic progression and prevention of physical disability. The Committee will also discuss general issues regarding claims based on radiographic data in patients with rheumatoid arthritis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 4/11/00-4/11/00

Meeting Details:

The committee will discuss biologics license application 99-0884, Enbrel (etanercept, Immunex), for an indication in patients with early rheumatoid arthritis.

 

       
Location: Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 7/21/99-7/21/99

Meeting Details:

The Committee will discuss the evidence needed to establish that a drug product has a beneficial effect on joint structure in patients with osteoarthritis. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Holiday Inn Gaithersburg Walker and Whetstone Roo Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

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

Meeting Details:

The Committee will discuss the safety and efficacy of new drug application (NDA) 21-042 Vioxx™ (rofecoxib, Merck) for the treatment of acute or chronic signs and symptoms of osteoarthritis and the management of pain.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 2/23/99-2/23/99

Meeting Details:

The committee will discuss issues in the design and assessment of clinical trials of drugs, biologics, and devices that are being developed for treatment of systemic lupus erythematosus.

 

       
Location: Holiday Inn Silver Spring Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 12/1/98-12/1/98

Meeting Details:

The Committee will discuss new drug application (NDA) 20-998 Celebrex™ (celecoxib, Searle) for the treatment of acute or chronic signs and symptoms of osteoarthritis and rheumatoid arthritis and the management of pain.

 

       
Location: Town Center Hotel The Maryland Ballroom 8727 Co Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 9/16/98-9/16/98

Meeting Details:

BLA 98-0286, Etanercept (EnbrelTM) Immunex.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 8/7/98-8/7/98

Meeting Details:

The committee will discuss the safety and efficacy of new drug application 20-905 Arava (leflunomide, Hoechst Marion Roussel, Inc., Germany) for the treatment of rhematiod arthritis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 3/24/98-3/25/98

Meeting Details:

On March 24, the committee will discuss safety issues, gastrointestinal tolerability, renal, bone and reproductive toxicity related to nonsteroidal anti-inflammatory drugs, for example, COX-2 and other agents. On March 25, the committee will discuss the pain claim structure for chronic and acute pain and onset of pain relief including appropriate study design for prescription and nonprescription oral analgesics.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 2/20/98-2/20/98

Meeting Details:

Guidance for Industry: Clinical Development Programs for Drugs, Devices and Biological Products Intended for the treatment of Osteoarthritis (OA)

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint meeting of the Nonprescription and the Arthritis Advisory Committee

Meeting Date: 7/15/97-7/15/97

Meeting Details:

The committee will hear presentations and discuss data submitted regarding New Drug Application (NDA) 20-802, Excedrin Extra Strength (acetaminophen, aspirin, caffeine) Tablets, Caplets, and Geltabs, 250 milligrams (mg), 250 mg, and 65 mg, respectively, Bristol Myers Squibb, for the pain of migraine.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 2/4/97-2/5/97

Meeting Details:

On February 4, 1997, the committee will hear presentations and discuss data submitted regarding the safety and efficacy of new drug application (NDA) 50-735, Neoral (cyclosporine, Sandoz) soft gelatin capsules and oral solution for microemulsion, for the treatment of severe rheumatoid arthritis. On February 5, 1997, the committee will review, discuss, and critique the draft document ``Guidance for Industry. Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA),'' including Juvenile Rheumatoid Arthritis (JRA).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Nonprescription and the Arthritis Drugs Advisory Committee

Meeting Date: 10/9/96-10/9/96

Meeting Details:

The committees will discuss new drug application (NDA) 20-373, S+ Ibuprofen (dexibuprofen, Sterling Winthrop/Bayer) 200-milligram caplet, indicated for the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, back ache, menstrual cramps, minor pain of arthritis, and for the temporary reduction of fever for OTC status.

 

       
Location: n/a Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 5/7/96-5/7/96

Meeting Details:

The committee will hear presentations and discuss data submitted regarding the safety and efficacy of NDA 20- 395, Enable (tenidap sodium), Pfizer, Inc., for use in the treatment of rheumatoid arthritis and osteoarthritis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 10/11/95-10/12/95

Meeting Details:

On October 11, 1995, the committee will consider issues presented in a citizen petition submitted by the Health Research Group of Public Citizen (Docket No. 94P-0458/CP1). The petition requests that FDA remove from the market drug products containing piroxicam, a nonsteroidal anti-inflammatory drug (NSAID), stating that the drug presents a significantly higher risk of gastropathy than other drugs in its class. The committee will examine safety data for the drug and advise FDA on whether piroxicam should be withdrawn from the market, whether changes in the drugs' labeling should be made, or whether no action need be taken. On October 12, 1995, the committee will examine the adequacy of the current gastropathy warnings in labeling for the class of NSAID's. Food Advisory Committee

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 7/14/95-7/14/95

Meeting Details:

On July 14, 1995, the Nonprescription Drugs Advisory Committee and the Arthritis Advisory Committee will discuss data relevant to NDA 20-499 (Bayer Corp.,) and NDA 20-429 (Whitehall-Robins Healthcare). Both NDA's are to switch ketoprofen (12.5 milligrams tablet/caplet) from prescription to over-the-counter status for the temporary relief of minor aches and pains associated with the common cold, toothache, muscular aches, backache, for the minor pain of arthritis, for the pain of menstrual cramps, and for reduction of fever.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Arthritis Drugs

Meeting Date: 3/27/95-3/28/95

Meeting Details:

During the morning of March 27, 1995, the Nonprescription Drugs Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee will discuss data relevant to new drug application (NDA) 18-751 to switch econazole nitrate cream 1% (Spectazole, Johnson & Johnson Consumer Products, Inc.) from prescription to OTC status for the treatment of tinea pedis (athlete's foot). During the afternoon of March 27, 1995, the Nonprescription Drugs Advisory Committee and representatives of the Pulmonary-Allergy Drugs Advisory Committee will discuss data relevant to the efficacy and use of antihistamines for the treatment of the common cold. In the morning on March 28, 1995, the Nonprescription Drugs Advisory Committee and the Arthritis Drugs Advisory Committee will discuss data relevant to NDA 20-512 for ibuprofen suspension (Motrin, McNeil Consumer Products) for the treatment of fever and of pain in children between 2 and 12 years of age. During the afternoon, the committees will discuss recommendations regarding appropriate OTC indication(s) for muscle relaxants, OTC dose(s) and duration of use, safety profiles, abuse potential, and pharmacokinetic information.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Arthritis Drugs

Meeting Date: 9/8/94-9/9/94

Meeting Details:

On September 8 and 9, 1994, the joint subcommittee will discuss effectiveness data requirements and proposed labeling indications for OTC analgesic drug products. The joint subcommittee will address topics such as: (1) Data requirements to support specific types of indications for OTC analgesic drug products; (2) recommendations for labeling indications for OTC analgesics; and (3) the current state of scientific knowledge in the areas of pain receptors, mechanism(s) of pain perception, and the basis for response to analgesic drug classes.

 

       
Location: September 8 and 9, 1994, 8:30 a.m., Parklawn Bldg., conference rms. D and E, 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 OptionsJoint Anesthetic and Analgesic with DSRM

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

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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 OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic with DSRM

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

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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 OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory

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

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Meeting Details:

The committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

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

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Meeting Details:

On Wednesday, September 16, 2015, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for DUREZOL (difluprednate ophthalmic emulsion) 0.05%, Phenylephrine Hydrochloride Ophthalmic Solution, ZYLET (loteprednol etabonate and tobramycin ophthalmic suspension), BETHKIS (tobramycin Inhalation Solution), INTELENCE (etravirine), PREZISTA (darunavir), VIRAMUNE XR (nevirapine), EPIDUO (adapalene and benzoyl peroxide), EXJADE (deferasirox), DOTAREM (gadoterate meglumine), FYCOMPA (perampanel), RECOTHROM (thrombin, topical [recombinant]), PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). As mandated by the Food and Drug Administration Amendments Act, Title III, Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110– 85), the committee will discuss the safety of and the ongoing propriety of the humanitarian device exemption for the PLEXIMMUNE, ELANA SURGICAL KIT (HUD), Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD), ENTERRA™ Therapy System, and CONTEGRA Pulmonary Valved Conduit.

 

       
Location: Double Tree by Hilton 8727 Colesville Road Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-6:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 9/24/15-9/24/15

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Meeting Details:

On September 24, 2015, the committee will discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization. The system, originally approved in November 2002, under P020014, consists of a delivery system and nickel-containing permanent implants. The implants are placed without a skin incision, through the vagina, within each fallopian tube; they elicit tissue ingrowth, which over time results in tubal occlusion.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 10/23/15-10/23/15

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Meeting Details:

The committee will discuss new drug application (NDA) 207988, lesinurad oral tablets, submitted by Ardea Biosciences, Inc., for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm

Meeting Date: 11/3/15-11/3/15

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Meeting Details:

The committee will discuss new drug application (NDA) 207959, enclomiphene citrate 12.5 milligram (mg) and 25 mg capsules, submitted by Repros Therapeutics, Inc., for the proposed treatment of secondary hypogonadism in fertile men (men with more than 15 million sperm/milliliter (ml)), younger than 60 years of age with a Body Mass Index (BMI) over 25 kilograms (kg)/meters squared (m2).

 

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

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