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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Adcomm - Teva Pharma

Meeting Date: 12/9/15-12/10/15

Meeting Details:

On Day 1 - December 9, 2015 - The committee will discuss biologics license application 761033, reslizumab for injection, submitted by Teva Pharmaceutical Industries, Ltd., for the proposed indication to reduce exacerbations, relieve symptoms, and improve lung function in adults and adolescents 12 years of age and above, with asthma and elevated blood eosinophils, who are inadequately controlled on inhaled corticosteroids. On Day 2 - December 10, 2015 - The committees will discuss the safety of codeine in children 18 years of age and younger. Codeine (most often in combination with acetaminophen) is used for the treatment of pain in children; however, it is contraindicated for the management of pain after tonsillectomy and/or adenoidectomy. Codeine (in combination with other medicines) is used for the relief of cough associated with upper respiratory allergies or the common cold in children. Codeine is available by prescription and also through the over-the-counter (OTC) Drug Monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products (21 CFR 341.14, 21 CFR 341.74, and 21 CFR 341.90). The focus of the meeting will be the risk of serious adverse events, such as respiratory depression and death, including reports in children who are CYP2D6 ultra-rapid metabolizers. The committees will discuss whether the use of codeine in children should be restricted further beyond the current contraindication described previously and whether codeine should be available through the OTC Drug Monograph.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPCNS AdComm - drisapersen by BioMarin Pharma

Meeting Date: 11/24/15-11/24/15

Meeting Details:

The committee will discuss new drug application (NDA) 206031, drisapersen solution for injection, sponsored by BioMarin Pharmaceutical Inc., for the treatment of patients with Duchenne muscular dystrophy with mutations in the dystrophin gene that are amenable to treatment with exon 51 skipping as determined by genetic testing.

 

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

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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    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Adcomm

Meeting Date: 5/12/15-5/12/15

Meeting Details:

The committee will discuss new drug application (NDA) 206038, lumacaftor/ivacaftor combination tablets for oral use, submitted by Vertex Pharmaceuticals, proposed for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 3/19/15-3/19/15

Meeting Details:

The committees will discuss supplemental new drug application 204275-S001, for fluticasone furoate and vilanterol inhalation powder (tradename Breo Ellipta) submitted by GlaxoSmithKline for the once daily maintenance treatment of asthma in patients 12 years of age and older. The discussion will include efficacy data, but the focus of the meeting will be safety, including the adequacy of the safety database to support approval, and whether a large safety trial to evaluate serious asthma outcomes is recommended.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 10/21/14-10/21/14

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 203188, ivacaftor oral tablets, submitted by Vertex Pharmaceuticals Inc., for the treatment of cystic fibrosis in patients with an R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 8/14/14-8/14/14

Meeting Details:

he committee will discuss the new drug application (NDA) 21936, for tiotropium bromide inhalation spray, submitted by Boehringer Ingelheim Pharmaceuticals, Inc. for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations. The discussion will include efficacy data, including the data to support the claim for reduction of COPD exacerbations, but the focus will be on safety findings from the clinical development program and the results of a large safety trial comparing tiotropium bromide inhalation spray and tiotropium bromide inhalation powder.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 9/10/13-9/10/13

Meeting Details:

On September 10, 2013, the committee will discuss the new molecular entity new drug application (NDA) 203975, for umeclidinium and vilanterol powder for inhalation (proposed trade name Anoro Ellipta), sponsored by Glaxo Group (d/b/a/GSK) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 4/17/13-4/17/13

Meeting Details:

The committee will discuss the new drug application (NDA) 204275, for fluticasone furoate and vilanterol dry powder inhaler (proposed trade name BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 3/7/13-3/7/13

Meeting Details:

On March 7, 2013, the committee will discuss the new drug application (NDA) 204275, for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 1/30/13-1/30/13

Meeting Details:

The committee will discuss the new drug application (NDA) 202049, for mannitol inhalation powder (proposed trade name BRONCHITOL), for oral inhalation sponsored by Pharmaxis, for the proposed indication of management of cystic fibrosis (CF) in patients aged 6 years and older to improve pulmonary function.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 1/29/13-1/29/13

Meeting Details:

The committee will discuss the new drug application (NDA) 203108, for olodaterol (proposed trade name Striverdi Respimat) metered dose inhaler, sponsored by Boehringer Ingelheim, for the proposed indication of long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 1/29/13-1/29/13

Meeting Details:

The committee will discuss the new drug application (NDA) 203108, for olodaterol (proposed trade name Striverdi Respimat) metered dose inhaler, sponsored by Boehringer Ingelheim, for the proposed indication of long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 2/23/12-2/23/12

Meeting Details:

The committee will discuss new drug application 202450, for aclidinium bromide, sponsored by Forest Laboratories, for the proposed indication of long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsFirazyr by Shire - Pulmonary-Allergy Drugs AdComm

Meeting Date: 6/23/11-6/23/11

Meeting Details:

On June 23, 2011, the committee will discuss the new drug application (NDA) 22150, icatibant solution for injection (proposed tradename Firazyr), Shire Human Genetic Therapies, for the proposed indication of treatment of acute attacks of hereditary angioedema

 

       
Location: Silver Spring, Maryland Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy AdComm

Meeting Date: 3/8/11-3/8/11

Meeting Details:

The Committee will discuss new drug application (NDA) No. 22-383, indacaterol maleate (Arcapta™ Neohaler™) by Novartis Pharmaceuticals Corporation, for the long-term once daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 4/7/10-4/7/10

Meeting Details:

On April 7, 2010, the committee will discuss new drug application (NDA) 22–522, roflumilast (DAXAS), Forest Research Institute, for the maintenance treatment of chronic obstructive pulmonary disease associated with chronic bronchitis in patients at risk of exacerbations (worsening symptoms).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 3/10/10-3/11/10

Meeting Details:

On March 10 and 11, 2010, the committee will discuss the design of medical research studies (known as ``clinical trial design'') to evaluate serious asthma outcomes (such as hospitalizations, a procedure using a breathing tube known as intubation, or death) with the use of the class of asthma medications known as long acting beta-2 adrenergic agonists in the treatment of asthma in adults, adolescents, and children.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 3/9/10-3/9/10

Meeting Details:

The committee will discuss new drug application (NDA) 22-535, pirfenidone, by InterMune. The proposed indication (purpose) of this drug is the treatment of patients with idiopathic pulmonary fibrosis (scarring of the lungs without a known cause) to decrease the decline in lung function associated with this condition.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 11/18/09-11/20/09

Meeting Details:

DAY 1: The committee will discuss biologics license application (BLA) 103976, supplement 5149, for XOLAIR (omalizumab), manufactured by Genentech USA, Inc. and Novartis Pharmaceuticals Corp. The proposed indication for this product is to treat moderate to severe persistent asthma in patients between 6 and 11 years of age whose symptoms are inadequately controlled with inhaled steroid medications and have: (1) A positive reaction to skin testing with common substances that can cause allergies and asthma, such as pollen or (2) in vitro reactivity, which is measured with a blood test that confirms the presence of specific proteins consistent with allergies and asthma. Day 2: The committee will discuss the efficacy supplement for new drug application (sNDA) 21395, for the approved product Spiriva HandiHaler (tiotropium inhalation powder), manufactured by Boehringer Ingelheim, for the reduction in exacerbations (worsening of symptoms) in patients with chronic obstructive pulmonary disease (COPD). Day 3: The committee will discuss new drug application (NDA) 22368, for ARIDOL (mannitol bronchial challenge test), manufactured by Pharmaxis Ltd. The proposed use of this product is to assess bronchial hyperresponsiveness (airway irritability in the lungs) to aid in diagnosing patients 6 years of age or older who have symptoms of asthma or symptoms that are suggestive of asthma.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 2/4/09-2/4/09

Meeting Details:

The committee will discuss biologics license application (BLA) No. 125277, KALBITOR, for ecallantide injection by Dyax Corp., for the proposed indication of treatment of acute attacks of hereditary angioedema.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy, DSRM, Pediatric AC

Meeting Date: 12/10/08-12/11/08

Meeting Details:

The committees will discuss the benefit risk assessment of long acting beta-2 adrenergic agonists for the treatment of asthma in adults and children.

 

       
Location: Hilton Washington DC/Rockville Rockville Pike, Rockville, MD. Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 2/20/08-2/20/08

Meeting Details:

The committee will discuss the new drug application (NDA) 22- 150, icatibant solution for injection (proposed tradename FIRAZYR), by Jerini, for the proposed indication of treatment of attacks of hereditary angioedema.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 5/1/07-5/1/07

Meeting Details:

The committee will discuss the efficacy supplement to new drug application (NDA) 21-077 for the approved product Advair Diskus(fluticasone propionate/salmeterol inhalation powder) by G1axoSmithKline, for the proposed indication of increased survival and reduced exacerbations in patients with chronic obstructive pulmonary disease (COPD).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 7/13/05-7/14/05

Meeting Details:

On July 13, 2005, the committee will discuss the implications of recently available data related to the safety of long-acting beta-agonist bronchodilators. On July 14, 2005, the committee will discuss the continued need for the essential use designations of prescription drugs for the treatment of asthma and chronic obstructive pulmonary disease under 21 CFR 2.125.

 

       
Location: Hilton Washington DC North Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

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

Meeting Details:

The committee will consider the safety and efficacy of new drug application (NDA) 50-799, proposed trade name PULMINIQ (cyclosporine, inhalation solution) Chiron Corporation, for use in combination with standard immunosuppressive therapy to increase survival and prevent chronic rejection in patients receiving allogenic lung transplants.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 6/10/04-6/10/04

Meeting Details:

The committee will discuss the possible removal of the essential use designation of albuterol under 21 CFR 2.125.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 9/5/03-9/5/03

Meeting Details:

On September 5, 2003, the FDA will discuss NDA 21-573 Ariflo by GSK for the use in chronic obstructive pulomnary disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 5/15/03-5/15/03

Meeting Details:

The committee will discuss biologics license application (BLA) 103976, Xolair Omalizumab (Humanized Monoclonal Antibody to Human IgE) by Genentech Incorporated, for the treatment of allergic asthma.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 12/20/02-12/20/02

Meeting Details:

MEETING POSTPONED UNTIL 2003: The committee will discuss new drug application (NDA) 20- 959, Ebastine by Almirall Prodesfarma, for the proposed indication of relief of nasal and nonnasal symptoms associated with seasonal and perennial allergic rhinitis in adults and children 12 years of age and older.

 

       
Location: Holiday Inn in Gaithersburg, Md. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 9/6/02-9/6/02

Meeting Details:

The committee will discuss new drug application (NDA) 21- 395, SPIRIVA (Tiotropium bromide) by Boehringer-Ingelheim, for chronic obstructive pulmonary disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary & Allergy Drugs Advisory Committee

Meeting Date: 1/17/02-1/17/02

Meeting Details:

The committee will discuss the use of Flovent Diskus (NDA# 20-833) and Advair Diskus (NDA# 21-077) as maintenance therapy in patients with Chronic Obstructive Pulmonary Disease (COPD).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 11/22/99-11/23/99

Meeting Details:

On November 22, 1999, the FDA will discuss its regulations related to ozone-depleting substances. In this discussion, FDA will review the Montreal Protocol on substances that deplete the ozone layer and the Advanced Notice of Proposed Rulemaking (ANPR) published on March 6, 1997 (FR Vol.62, No. 4410242), as discussed at the April 11, 1997, PADAC. The FDA will provide an overview and detailed discussion of the notice of proposed rulemaking (NPR),published on September 1, 1999 (FR Vol. 64 No. 169 47719), related to the phase-out of chloroflurocarbons (CFCs) in metered-dose inhalers. This NPR outlines the mechanism by which FDA will determine when the use of ozone-depleting substances, including CFCs in metered-dose, inhalers, in any product regulated by FDA is no longer essential under the Clear Air Act. On November 23, 1999, the committee will discuss the safety and 0efficacy of new drug application (NDA) 21-077 for three products: Advair™ Diskus® 100 mcg (salmeterol xinafoate 50 mcg/fluticasone propionate 100 mcg inhalation powder), Advair™ Diskus® 250 mcg (salmeterol xinafoate 50 mcg/fluticasone propionate 250 mcg inhalation powder), Advair™ Diskus® 500 mcg (salmeterol xinafoate 50 mcg/fluticasone propionate 500 mcg inhalation powder), Glaxo Wellcome, for the maintenance treatment of asthma as prophylatic therapy in patients 12 years of age and older.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs

Meeting Date: 12/15/97-12/15/97

Meeting Details:

The Committee will discuss the safety and efficacy of new drug application (NDA) 20-793, Cafcit (caffeine citrate injection, 10 milligram/milliliter), Roxane Laboratories, Inc., for intravenous or oral use in the treatment of apnea of prematurity.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary Allergy Drugs Advisory Committee

Meeting Date: 4/11/97-4/11/97

Meeting Details:

FDA staff will present to the committee the agency's advance notice of proposed rulemaking, which proposes a strategy for the withdrawal of the essential use status of marketed chlorofluorocarbon (CFC) products as proven alternatives become available. A representative from the U.S. Environmental Protection Agency will present an overview of the environmental impact of CFC's and a review of the Montreal Protocol on ozone-depleting substances. The committee will discuss and comment upon the agency's proposed strategy for the CFC-transition process and on presentations made during the open public hearing. Advisory committee input, in addition to open public hearing comments, will be considered by the agency as it formulates subsequent rulemaking related to the CFC-transition process.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Nonprescription and the Pulmonary-Allergy Drugs Advisory Committee

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

Meeting Details:

On October 10, 1996, the committees will jointly consider NDA 20-463, Nasalcrom (Cromolyn Sodium Nasal Solution, United States Pharmacopeia) for OTC treatment of seasonal allergic rhinitis sponsored by McNeil Consumer Products Co. On October 11, 1996, the committees will jointly consider the prescription to OTC switch of NDA 19-589, Vancenase AQ Nasal Spray (Beclomethasone Dipropionate) for the treatment of seasonal allergic rhinitis sponsored by Schering-Plough Pharmaceutical Co. National Mammography Quality Assurance Advisory Committee

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

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

Meeting Details:

The committee will discuss Genentech's clinical labeling supplement to modify the current prescribing information for Pulmozyme (dornase alfa) pertaining to cystic fibrosis patients with forced vital capacity of the lung, less than 40 percent of predicted capacity.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 3/28/96-3/29/96

Meeting Details:

On March 28, 1996, the committee will discuss Zeneca Pharmaceuticals' new drug application (NDA) 20-547 for Accolate (zafirlukast) tablets. The proposed indication for Accolate is as an oral anti-inflammatory agent for use in the prophylaxis and chronic treatment of asthma and as a first-line maintenance therapy in patients with asthma who are not adequately controlled by PRN 2-agonist alone. On March 29, 1996, the committee will discuss 3M Pharmaceuticals' NDA 20-503 for Epaq TM, an albuterol metered-dose inhaler which is the first to utilize a hydrofluoroalkane propellent. The proposed indication is for treatment or prevention of bronchospasm in patients with reversible obstructive airway disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 11/17/95-11/17/95

Meeting Details:

The committee will be briefed on the Pediatric Labeling Rule and the data necessary to support pediatric labeling of drugs. The committee will discuss NDA 20-114, Astelin nasal spray (azelastine), for seasonal allergic rhinitis. The sponsor is Carter-Wallace, Inc.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 11/16/95-11/16/95

Meeting Details:

The committees will first discuss data relevant to investigational new drug (IND) 41,743, sponsored by Sandoz Pharmaceuticals Corp., on the efficacy of clemastine fumarate in the common cold. The committees will then discuss a meta-analysis of data on antihistamines and the common cold to address the inclusion of the common cold indication for the over-the-counter antihistamines, which is currently in the tentative final monograph, in the final monograph.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs

Meeting Date: 9/25/95-9/25/95

Meeting Details:

The committee will discuss two NDA's: (1) NDA 20-548, Flovent TM Inhalation Aerosol (a metered-dose inhaler formulation of fluticasone propionate), and (2) NDA 20-549, Flovent TM Inhalation via Diskhaler (a dry powder formulation of fluticasone propionate). Both NDA's are indicated for the maintenance treatment of bronchial asthma and for treatment of patients requiring oral corticosteroid therapy for asthma who may be able to significantly reduce or eliminate their requirement for oral corticosteroids over time. The sponsor for both NDA's is Glaxo Welcome.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs

Meeting Date: 4/10/95-4/10/95

Meeting Details:

The committee will discuss new drug application (NDA) 20-471, Abbott Laboratories, Leutrol (zileuton) as an anti-asthmatic drug.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Pulmonary-Allergy Drugs

Meeting Date: 11/14/94-11/15/94

Meeting Details:

The committees will jointly discuss over-the-counter (OTC) drug products for the treatment of asthma and will address topics such as: (1) OTC bronchodilator drug products currently available and possible pending changes in their marketing status; (2) whether there is a population for which OTC antiasthma drug products are appropriate; (3) the general question of whether antiasthma drug products should be available OTC; (4) antiasthma drug products currently available by prescription only that could be considered for OTC status; and (5) data requirements necessary to support conversion of prescription antiasthma drug products to OTC status.

 

       
Location: November 14, 1994, 8:30 a.m., Parklawn Bldg., conference rms. G through J, FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs

Meeting Date: 7/14/94-7/15/94

Meeting Details:

On July 14, 1994, the committee will discuss new drug application (NDA) 20-291, Boehringer Ingelheim Pharmaceuticals, Inc., Combivent Inhalation Aerosol: (ipratropium bromide and albuterol sulfate) for the treatment of bronchospasm associated with chronic obstructive pulmonary disease. The committee will also be briefed on general points to consider for inhalational drug product development. On July 15, 1994, the committee will discuss: (1) NDA 20-393, Boehringer Ingelheim Pharmaceuticals, Inc., Atrovent Nasal Spray 0.03% (ipratropium bromide) for the symptomatic relief of rhinorrhea associated with perennial rhinitis, and (2) NDA 20-394, Boehringer Ingelheim Pharmaceuticals, Inc., Atrovent Nasal Spray 0.06% (ipratropium bromide) for the symptomatic relief of rhinorrhea associated with the common cold. Closed committee deliberations. The committee will discuss trade secret and/or confidential commercial information relevant to pending 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 14 and 15, 1994, 8 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 OptionsOncologic Drugs AdComm

Meeting Date: 9/14/16-9/14/16

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Meeting Details:

The committee will discuss new drug application 208714, apaziquone for intravesical instillation, application submitted by Spectrum Pharmaceuticals, Inc. The proposed indication (use) for this product is for immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer.

 

       
Location: Conference Center Related News Links: Not Available
Time: 8:00AM-1:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting: Psychopharmacologic & DSRM Drugs AdComm

Meeting Date: 9/14/16-9/14/16

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Meeting Details:

The committees will discuss a completed postmarketing-requirement randomized, placebo controlled trial of the neuropsychiatric effects of CHANTIX (varenicline), ZYBAN (bupropion), and nicotine replacement therapy, along with relevant published observational studies to determine whether the findings support changes to product labeling.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting-Anesthetic and Analgesic Drug Products AC, the DSRM AC, and the Pediatric AC

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

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Meeting Details:

The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 9/20/16-9/21/16

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Meeting Details:

On September 20 and 21, 2016, the Committee will discuss and make recommendations regarding the classification of certain wound care products containing antimicrobials and other drugs as part of the routine process for device classification. These products are regulated under product code FRO, "Dressing, Wound, Drug," and are considered "pre-amendments" because they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments were enacted, and have not yet been classified under section 513 of the Federal Food, Drug, and Cosmetic Act. As a part of the classification process, FDA is seeking committee input on the indications for use, risks to health, and safety and effectiveness of these wound care products, and how they should be classified. They may be classified in class I (general controls), class II (special and general controls), or class III (premarket approval (PMA), requiring demonstration of safety and effectiveness for each product). FDA believes some of these products may meet the definition of class II whereas others may meet the definition of class III in light of their intended use, composition, the extent of evidence of clinical benefit, and the risks they pose. For the subset of the these products that contain antibiotics, FDA appreciates the importance of appropriately addressing the risk of antimicrobial resistance (AMR) in light of the increasingly significant national public health concern posed by AMR. FDA is also aware of differences in the claims made for some products even though they may be regulated in the same manner.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic & Analgesic & DSRM Drug Adcomm

Meeting Date: 10/5/16-10/5/16

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Meeting Details:

The committees will be asked to discuss naloxone products intended for use in the community, specifically the most appropriate dose or doses of naloxone to reverse the effects of life-threatening opioid overdose in all ages, and the role of having multiple doses available in this setting. The committees will also be asked to discuss the criteria prescribers will use to select the most appropriate dose in advance of an opioid overdose event and the labeling to inform this decision, if multiple doses are available.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting of the Bone, Reproductive and Urologic Drugs Advisory Committee

Meeting Date: 10/19/16-9/19/16

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Meeting Details:

The committee will discuss the efficacy and safety of new drug application (NDA) 201656 (desmopressin), 0.75 mcg/0.1 mL and 1.5 mcg/0.1 mL nasal spray, submitted by Serenity Pharmaceuticals, LLC, for the proposed treatment of adult onset nocturia.

 

       
Location: tbd Related News Links: Not Available
Time: 8:15AM-6:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMicrobiology Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 8/16/16-8/16/16

Meeting Details:

On August 16, 2016, the committee will discuss and make recommendations regarding the appropriateness of clearing or approving of over-the-counter (OTC) diagnostic tests for the detection of pathogens causing infectious diseases, focusing on respiratory and sexually transmitted infections (STI). Currently, there are no OTC diagnostic tests for infectious diseases cleared or approved by CDRH. The committee will evaluate the risks and benefits to individual patients and to public health associated with clearing or approving OTC diagnostic tests for infectious diseases. Serious risks such as false negative results, false positive results, patient loss to medical followup, and the impact on surveillance of reportable infections will be addressed. Potential benefits such as reduction of infection transmission and increased access to testing will be discussed as well. The committee will also make recommendations on clinical study design, analytical study design, and acceptable performance criteria applicable to respiratory and STI diagnostic devices.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry & Clinical Toxicology Devices Panel of the Medical Devices AdComm

Meeting Date: 8/10/16-8/10/16

Meeting Details:

On August 10, 2016, the committee will discuss, make recommendations, and vote on information regarding a de novo request for the SEEKER Newborn Screening System (SEEKER System), by Baebies, Inc. The SEEKER System consists of the SEEKER Analyzer, the SEEKER 4-Plex Assay Kit, the SEEKER Cartridges, the Spot Logic software, and quality control materials; it uses digital microfluidic technology to measure multiple lysosomal enzymatic activities quantitatively from newborn dried blood spot specimens.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Anesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 8/4/16-8/4/16

Meeting Details:

The committees will discuss new drug application (NDA) 208630, morphine sulfate extended-release tablets, submitted by Egalet U.S., Inc., with the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It has been formulated with the intent to provide abuse-deterrent properties. The committees will be asked to discuss whether the data submitted by the applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

 

       
Location: tbd Related News Links: Not Available
Time: 9:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue, and Gene Therapies Advisory Committee

Meeting Date: 7/26/16-7/26/16

Meeting Details:

On July 26, 2016, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Molecular Oncology and the Laboratory of Biological Chemistry, Division of Biotechnology Review and Research 1 and 4, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, FDA.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 1:00PM-3:30PM    
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.

Live Meetings

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