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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm - Sponsor: Shire

Meeting Date: 10/18/18-10/18/18

Meeting Details:

The committee will discuss new drug application (NDA) 210166 for prucalopride tablets for oral administration, submitted by Shire Development, LLC, proposed for the treatment of chronic idiopathic constipation in adults.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Gastrointestinal & DSRM AdComm - Sponsor: Sloan Pharma

Meeting Date: 10/17/18-10/17/18

Meeting Details:

The committees will discuss supplemental new drug application (sNDA) 021200, supplement 015, for ZELNORM (tegaserod maleate) tablets for oral administration, submitted by Sloan Pharma S.[agrave].r.l, Bertrange, Cham Branch, proposed for the treatment of women with irritable bowel syndrome with constipation who do not have a history of cardiovascular ischemic disease, such as myocardial infarction, stroke, transient ischemic attack, or angina, and who do not have more than one risk factor for cardiovascular disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastro and Pediatric AdComm

Meeting Date: 5/3/18-5/3/18

Meeting Details:

The committees will discuss new drug application (NDA) 209904, for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia.

 

       
Location: DoubleTree by Hilton Hotel Bethesda Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 3/8/18-3/8/18

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 203214, supplement 18, XELJANZ (tofacitinib) 5 mg and 10 mg tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response, loss of response or intolerance to corticosteroids, azathioprine, 6-mercaptopurine or tumor necrosis factor (TNF) inhibitor therapy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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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Meeting OptionsMeeting OptionsMeeting Options*** Meeting Delay *** Joint GIDAC & DSaRM

Meeting Date: 12/9/13-12/9/13

Meeting Details:

On December 9, 2013, the committees will discuss two biologics license applications (BLAs) for vedolizumab injection (proposed tradename Entyvio), submitted by Millennium Pharmaceuticals, Inc. BLA 125476 proposes an indication for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFa) antagonist. BLA 125507 proposes an indication for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a TNFa antagonist.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 10/16/12-10/16/12

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 203441, with the proposed trade name GATTEX (teduglutide) for subcutaneous injection, by NPS Pharmaceuticals, Inc, for the proposed indication of treatment of adult patients with short bowel syndrome.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsCancelled - Gastrointestinal Drugs AdComm

Meeting Date: 10/15/12-10/15/12

Meeting Details:

The committee will provide advice and recommendations to the Agency on the need for and design of clinical development programs necessary to support approval of parenteral lipid emulsion products as nutritional support. FDA intends to make background material available to

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs Advisory Committee

Meeting Date: 8/28/12-8/28/12

Meeting Details:

The committee will discuss the results from clinical trials of supplemental biologics license application (sBLA) 125057/232, for Humira (adalimumab), by Abbott Laboratories, for the proposed indication (use) for reducing signs and symptoms, and achieving clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

 

       
Location: DoubleTree by Hilton Hotel Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs Advisory Committee

Meeting Date: 3/13/12-3/13/12

Meeting Details:

The committee will discuss and provide general advice on the appropriate target populations, objectives and designs of trials intended to evaluate products for the control of hyperbilirubinemia (increased levels of bilirubin in the body) in newborn infants.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs Advisory Committee

Meeting Date: 11/16/11-11/17/11

Meeting Details:

On November 16th, the committee will discuss the design of clinical trials to evaluate the safety, efficacy and durability of response with repeat treatment cycles of XIFAXAN (rifaximin) by Salix Pharmaceuticals, Inc., for irritable bowel syndrome with diarrhea. On November 17th, the committee will provide recommendations to the Agency on the design and size of premarketing cardiovascular safety development programs necessary to support approval of products in the class of serotonin (5-hydroxytryptamine) receptor 4 (5HT4) agonists for the proposed indications of chronic idiopathic (of unknown cause) constipation (CIC), constipation predominant irritable bowel syndrome (IBS-C), gastroparesis, and gastroesophageal reflux disease that does not respond to a proton pump inhibitor.

 

       
Location: Hilton Inn Washington/College Park Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsREMICADE by Centocor - Gastrointestinal Drugs AdComm

Meeting Date: 7/21/11-7/21/11

Meeting Details:

On July 21, 2011, the committee will discuss the results from a clinical trial of supplement biologics license application 103772/5301, REMICADE (infliximab), by Centocor Ortho Biotech Inc., in the treatment of pediatric patients with moderately to severely active ulcerative colitis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 1/12/11-1/12/11

Meeting Details:

On January 12, 2011, the committee will discuss the safety and efficacy of new drug application (NDA) 022-486, for Solpura (liprotamase) Capsules, by Alnara Pharmaceuticals, for the proposed indication (use) in the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy (surgical removal of all or part of the pancreas), or other conditions that may impair or limit function of the pancreas. The pancreas is an organ involved, in part, in the digestion of food through the use of specialized proteins called enzymes. Exocrine pancreatic insufficiency is a decreased ability to digest food due to deficient enzyme production by the pancreas.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 11/4/10-11/5/10

Meeting Details:

On November 4, 2010, the committee will discuss the adequacy of endoscopically documented gastric ulcers as an outcome measure to evaluate drugs intended to prevent gastrointestinal complications of nonsteroidal anti-inflammatory drugs including aspirin. The purpose of this meeting is to discuss results from clinical trials of proton pump inhibitors in astroespohageal reflux disease (GERD) in patients less than one year of age, performed in response to a Pediatric Written Request under the Best Pharmaceuticals for Children Act (Nexium, esomeprazole by AstraZeneca LP; Prevacid, lansoprazole by Takeda Pharmaceuticals North America, Inc; Protonix, pantoprazole by Pfizer, Inc.) and Pediatric Research Equity Act (PREA) commitment (Prilosec, omeprazole by AstraZeneca LP). The pathophysiology (disease process) of GERD, its diagnosis and management, and issues related to the design of clinical trials in this age group will be considered.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm - Salix Pharmacueticals

Meeting Date: 2/23/10-2/23/10

Meeting Details:

The committee will discuss the efficacy and safety of new drug application (NDA) 22-554 for XIFAXAN (rifaximin) Tablets 550 mg, manufactured by Salix Pharmaceuticals, for the indication (use) of maintenance of remission of hepatic encephalopathy, a condition in which severe liver disease contributes to an accumulation of toxic substances that impair brain function. This indication is for patients 18 years of age and older.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm - Day 2 Cancelled

Meeting Date: 5/19/09-5/20/09

Meeting Details:

On May 19th the committee will discuss the safety and efficacy of new drug application (NDA) 21761, SANVAR (vapreotide acetate) by Debiovision, Inc., for the proposed indication as an adjunctive therapy to endoscopic intervention for the control of acute esophageal bleeding as a result of portal hypertension.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 1/23/08-1/23/08

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 21-775, ENTEREG (alvimopan), Adolor Corp., for the proposed indication of acceleration of time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Gastrointestinal and DSRM AdComm

Meeting Date: 7/31/07-7/31/07

Meeting Details:

The committee will discuss TYSABRI (natalizumab) biologic license application (BLA) 125104/33, Biogen Idec, Inc., for the proposed indication of inducing and maintaining sustained response and remission, and eliminating corticosteroid use in patients with moderately to severely active Crohn's disease with inflammation, as evidenced by elevated C-reactive protein level or another objective marker. The committee will discuss the risks (including progressive multifocal leukoencephalopathy) associated with TYSABRI (natalizumab) administration, its efficacy in the treatment of moderate to severe Crohn's disease, and proposed risk management plan(s).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 3/9/05-3/9/05

Meeting Details:

The FDA will meet to discuss Solvay Pharmaceutical Inc. Cilansetron. Related Link From Yahoo

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs Advisory Committee

Meeting Date: 7/14/04-7/14/04

Meeting Details:

The FDA will meet to consider Zelnorm by Novartis for the treatment of chronic constipation.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 6/25/03-6/26/03

Meeting Details:

On June 25, the committee will discuss new drug application (NDA) 21-297, SEROSTIM (somatropin), Serono, Inc., for the treatment of short bowel syndrome in patients receiving specialized nutritional support. SEROSTIM therapy should be used in conjunction with optimal management of short bowel syndrome. On June 26, the committee will discuss NDA 21-525, PHOTOFRIN (porfirmer sodium), Axcan Scandipharm, Inc. Photodynamic therapy with PHOTOFRIN is indicated for the ablation of high-grade dysplasia in Barrett’s esophagus among patients who refuse esophagectomy and who are in overall good health.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs Advisory Committee

Meeting Date: 3/6/03-3/6/03

Meeting Details:

On March 6, 2003, the committee will discuss new drug application (NDA) 21-549, EMEND (aprepitant) Capsules, Merck & Co., Inc., for the following indication: "EMEND, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin."

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs Advisory Committee

Meeting Date: 4/23/02-4/23/02

Meeting Details:

GlaxoSmithKline Lotronex (alosetron) Discussion of risk management issues for withdrawn drug

 

       
Location: TBA Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs Advisory Committee

Meeting Date: 3/19/02-3/19/02

Meeting Details:

The committee will discuss standards in study designs of clinical trials testing the efficacy and safety of chemopreventive agents that are being developed to gain FDA approval in reducing the risk of sporadic colorectal adenomatous polyps and sporadic colorectal cancer.

 

       
Location: TBA Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 6/26/00-6/27/00

Meeting Details:

On June 26, 2000, the committee will discuss new drug application (NDA) 21-200, Zelmac TM (tegaserod), Novartis Pharmaceuticals Corp., for the treatment of abdominal pain and discomfort, bloating and altered bowel function in patients with irritable bowel syndrome who have predominant symptoms of pain, discomfort, and constipation. On June 27, 2000, the committee will discuss risk management of post-marketing adverse events associated with NDA 21-107, LotronexTM (alosetron) Glaxo Wellcome.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 4/12/00-4/12/00

Meeting Details:

The committee will discuss current information on the safety of Janssen Pharmaceutica's Propulsid(cisapride) and methods to reduce the occurrence of adverse events associated with its use.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 11/16/99-11/16/99

Meeting Details:

The committee will discuss new drug application (NDA) 21-107, Lotronex™ (alosteron HCI), Glaxo-Wellcome Pharmaceuticals, to be indicated for treatment of irritable bowel in female patients with diarrhea predominance.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 5/28/98-5/29/98

Meeting Details:

On May 28, 1998, the Committee will discuss biologics license application, 98-0012, Centocor, Inc’s Avakine™ (Infliximax), for treatment of patients with Crohn’s disease. An indication is sought to: 1)reduce signs and symptoms in patients with moderate to severe disease activity in whom conventional therapies are inadequate and, 2) to close entercutaneous fistulas. On May 29, 1998, the Committee will hold a general discussion on guidance for study of drugs to treat Crohn’s disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 11/4/96-11/5/96

Meeting Details:

On November 4, 1996, the committee will discuss data concerning the safety of long-term antisecretory therapy in patients with Helicobacter pylori; new drug application (NDA) 19- 810, Prilosec (omeprazole, Astra Merck), delayed release capsules; and NDA 20-406, Prevacid (lansoprazole, TAP Holding Co.), delayed release capsules. On November 5, 1996, the committee will discuss NDA 20-675 (ureodeoxycholic acid, Axcan Pharma), for the treatment of patients with primary biliary cirrhosis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Gastrointestinal Drugs

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

Meeting Details:

Nonprescription Drugs Advisory Committee and some members of the Gastrointestinal Drugs Advisory Committee will discuss data relevant to NDA 20-555 for nizatidine tablets, 75 mg, sponsored by Whitehall-Robins Healthcare to switch the product from prescription to over-the-counter status for the prevention of meal and beverage induced heartburn.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Gastrointestinal Drugs

Meeting Date: 7/13/95-7/13/95

Meeting Details:

On July 13, 1995, the Nonprescription Drugs Advisory Committee and the Gastrointestinal Drugs Advisory Committee will discuss data relevant to NDA 20-520 to switch Zantac 75 (ranitidine hydrochloride tablets) (Glaxo, Inc.) from prescription to over-the-counter status for the treatment of heartburn.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 7/12/95-7/12/95

Meeting Details:

The committee will discuss new drug application (NDA) 20-458, Lemmon Co., zinc acetate to be indicated for use in Wilson's disease. The advisory committee will also consider draft ``Points to Consider'' from the Division of Anti-Infective Drug Products on Helicobacter pylori studies to prevent peptic ulcer recurrence.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Gastrointestinal Drugs

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

Meeting Details:

On March 27, 1995, the Nonprescription Drugs Advisory Committee and the Gastrointestinal Drugs Advisory Committee will discuss SmithKline Beecham's NDA 20-238 for over-the- counter (OTC) Tagamet (cimetidine) tablets for the treatment of heartburn. On the morning of March 28, 1995, the Nonprescription Drugs Advisory Committee and the Arthritis Advisory Committee will discuss data relevant to NDA 20-516 for ibuprofen suspension (Motrin, McNeil Consumer Products) for the treatment of fever and of pain in children between 2 and 12 years of age. On the afternoon of March 28, 1995, the Nonprescription Drugs Advisory Committee and the Arthritis Advisory Committee 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 OptionsGastrointestinal Drugs

Meeting Date: 12/1/94-12/2/94

Meeting Details:

On December 1, 1994, the committee will discuss new drug application (NDA) 20-406, TAP Pharmaceuticals, Prevacid (lansoprazole), to be indicated for the treatment of reflux esophagitis, maintenance of healing of reflux esophagitis, duodenal ulcer and hypersecretory conditions including Zollinger- Ellison syndrome. On December 2, 1994, the committee will discuss NDA 19-810, Astra-Merck, Prilosec (omeprazole) for maintenance treatment of gastroesophageal reflux disease.

 

       
Location: December 1, 1994, 9 a.m., and December 2, 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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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Gastrointestinal Drugs

Meeting Date: 7/29/94-7/29/94

Meeting Details:

The committees will discuss NDA 20-325, Pepcid (famotidine), Merck and Co., for treatment and prevention of episodic heartburn.

 

       
Location: July 29, 1994, 9 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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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 7/28/94-7/28/94

Meeting Details:

The committee will discuss NDA 19-594 (supplement 015), Ciba-Geigy Corp., Actigall (ursodiol) for treatment of primary biliary cirrhosis. Closed committee deliberations. The committee will discuss trade secret and/or confidential commercial information relevant to pending investigational NDA's. This portion of the meeting will be closed to permit discussion of this information (5 U.S.C. 552b(c)(4)).

 

       
Location: July 28, 1994, 9 a.m., Parklawn Bldg., conference rms. G, H, I, and J, 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Gastrointestinal Drugs

Meeting Date: 7/27/94-7/28/94

Meeting Details:

The committees will jointly discuss new drug application (NDA) 20-238, Tagamet (cimetidine), SmithKline Beecham, for treatment of episodic heartburn as an over-the-counter product.

 

       
Location: July 27, 1994, 9 a.m., conference rms. D and E, Parklawn Bldg., 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 OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 12/10/19-12/10/19

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Meeting Details:

The committee will be asked to discuss new drug application (NDA) 022034, for vernakalant HCl solution, for intravenous injection, submitted by Correvio International Sàrl, for the proposed indication of rapid conversion of recent onset atrial fibrillation to sinus rhythm for non-surgery patients: Atrial fibrillation = 7 days duration, and for post-cardiac surgery patients: Atrial fibrillation = 3 days duration.

 

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

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm - Sponsor: Amarin Pharma Inc.

Meeting Date: 11/14/19-11/14/19

Meeting Details:

The committee will discuss supplemental new drug application 202057/S-035, for VASCEPA (icosapent ethyl) capsules for oral administration, sponsored by Amarin Pharma Inc., for the following proposed indication: To reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease, based on the results of a clinical study entitled “A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)”

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices Panel

Meeting Date: 11/13/19-11/14/19

Meeting Details:

On November 13 and 14, 2019, the committee will discuss the topic of immunological responses to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam. Implants are medical devices that are placed into a surgically or naturally formed opening of the human body and are intended to remain there after the procedure for an extended period of time (typically, greater than 30 days). For decades, metal-containing implants have been used in a large number of medical specialties including cardiology, orthopedics, dentistry, gastroenterology, and neurology or neurosurgery. Recent postmarket issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological responses to the implant. These may include local (peri-implant) adverse events and potentially systemic manifestations, which may impact a patient's quality of life and necessitate medical or surgical intervention. While not considered an implant, dental amalgam is included in this discussion because of its potential for patient and user exposure to mercury compounds and some purported similarities in the adverse biological responses and clinical manifestations elicited by some dental amalgams to that of traditional metal implants.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm - Sponsor: Boehringer Ingelheim

Meeting Date: 11/13/19-11/13/19

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 204629/S-020 for empagliflozin oral tablet, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the following proposed indication: As an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 11/8/19-11/8/19

Meeting Details:

On November 8, 2019, the Center for Biologics Evaluation and Research's (CBER) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss and make recommendations on the development of chikungunya vaccines.

 

       
Location: The Great Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral Hospital and Personal Use Devices Panel

Meeting Date: 11/6/19-11/7/19

Meeting Details:

On November 6 and 7, 2019, the committee will discuss the topic of industrial ethylene oxide (EtO) sterilization of medical devices and its role in maintaining public health as well as the risks of infection with reprocessed duodenoscopes. Subject matter of the panel meeting will include potential methods and expert assessment of how to reduce EtO emissions to the environment from medical device sterilization processes without compromising assurance of sterility or effective processing of medical devices. The panel will also discuss recommendations to reduce the risk of infection from reprocessed duodenoscopes.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic AdComm
Sponsor: Agile Therapeutics, Inc.

Meeting Date: 10/30/19-10/30/19

Meeting Details:

The committee will discuss new drug application (NDA) 204017 (levonorgestrel and ethinyl estradiol) transdermal system, submitted by Agile Therapeutics, Inc., for the prevention of pregnancy in women of reproductive potential.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm
Sponsor: AMAG Pharmaceuticals

Meeting Date: 10/29/19-10/29/19

Meeting Details:

The committee will discuss supplemental new drug application (sNDA 021945/S-023#) for MAKENA (hydroxyprogesterone caproate injection, 250 milligrams per milliliter) manufactured by AMAG Pharmaceuticals. In 2011, MAKENA received approval under the accelerated approval pathway (21 CFR part 314, subpart H, and section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) for reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. MAKENA was shown in the preapproval clinical trial to reduce the proportion of women who delivered at less than 37 weeks gestation, a surrogate endpoint that FDA determined was reasonably likely to predict a clinical benefit of preterm birth prevention, such as improved neonatal mortality and morbidity. As required under 21 CFR 314.510, the Applicant conducted a postapproval confirmatory clinical trial to verify and describe clinical benefit. AMAG Pharmaceuticals has disclosed that this completed confirmatory trial did not demonstrate a statistically significant difference between the treatment and placebo arms for the co-primary endpoints of reducing the risk of recurrent preterm birth or improving neonatal mortality and morbidity. The committee will consider the trial's findings and the sNDA in the context of AMAG Pharmaceuticals' confirmatory study obligation.

 

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

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