FDA News March 23, 2011


Risk of oral birth defects in children born to mothers taking topiramate

New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy.

 

 

 

FDA modifies boxed warning for pulmonary arterial hypertension drug Letairis

The FDA announced that monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).  More information

 

 

Product Approvals:

For information on drug approvals, please visit Drugs@FDA

Opportunities for Comment:

Announcements:

Upcoming Meetings:

  • Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging
    Date:  March 30 and 31, 2011

    Time:  8:00 a.m. to 5:30 p.m.
    Location:  Holiday Inn Gaithersburg, 2 Montgomery Village Avenue, Gaithersburg, MD 20879Contact:  Simon Choi, PhD, MPH, Phone: 301-796-5426, E-mail:CDRHImagingInitiative@fda.hhs.gov

    FDA has published a notice in the Federal Register announcing a public meeting on March 30-31, 2011, and requesting comments on a number of questions regarding steps that could be taken by manufacturers of devices used in computed tomography (CT) and in fluoroscopy that would help reduce unnecessary patient exposure to ionizing radiation during CT and fluoroscopic procedures.  Please see Docket No. FDA-2010-N-0080. Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging; Public Meeting, Request for Comments.  Comments are due by April 15, 2011.

  • Food Advisory Committee Meeting
    Date:  March 30-31, 2011

    Time:  8:30 a.m. to 4:30 p.m.
    Location:  Hilton Hotel, 8727 Colesville Road, Silver Spring, MD 20910
    Contact:  Carolyn Jeletic, Office of Regulations, Policy and Social Sciences, HFS-024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, Maryland 20740, Phone: 301-436-1913, E-mail: Carolyn.Jeletic@fda.hhs.gov

    The committee will meet to discuss whether available relevant data demonstrate a link between children’s consumption of synthetic color additives in food and adverse effects on behavior.

  • Anti-Infective Drugs Advisory Committee Meeting
    Date:  April 5, 2011
    Time:  8:30 to 4:00 p.m.
    Location:  Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Road, Silver Spring, Maryland
    Contact:  Minh Doan, Pharm.D., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, WO31-2417, Silver Spring, MD 20993, Phone: 301-796-9001, E-mail:
    minh.doan@fda.hhs.gov

    The committee will discuss new drug application (NDA) 20-1699, for FIDAXOMICIN tablets, submitted by Optimer Pharmaceuticals, Inc., for the requested indication of treatment of adults with Clostridium difficile infection (CDI), also known as Clostridium difficile-associated diarrhea (CDAD), and prevention of recurrences.

  • Vaccines and Related Biological Products Advisory Committee Meeting
    Date:  April 6 and 7, 2011
    Time:  9:00 to 4:00 p.m – Apr 6; 8:30 to 3:30 p.m. – Apr 7
    Location:  Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry Parkway
    Gaithersburg, MD 20877

    Contact:  Donald Jehn or Denise Royster, 1401 Rockville Pike, HFM-71, Rockville, MD 20852, Phone: 301-827-0314, E-mail: Donald.Jehn@fda.hhs.gov or denise.royster@fda.hhs.gov

    On the morning of April 6, 2011, the committee will meet in open session to hear updates of the research programs in the Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, & Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. In the afternoon of April 6, 2011, the committee will meet in open session and will be briefed on the use of immunological markers for demonstration of effectiveness of meningococcal serogroups A,C,Y and W-135 conjugate vaccines administered to children less than 2 years of age. On April 7, 2011, the committee will meet in open session to review and discuss approaches to licensure of meningococcal serogroup B vaccines.

  • 510(k) Implementation: Discussion of an On-line Repository of Medical Device Labeling, and of Making Device Photographs Available in a Public Database Without Disclosing Proprietary Information
    Date:  April 7, 2011
    Time:  8:30 a.m. to 5:00 p.m.
    Location:  FDA White Oak Campus, 10903 New Hampshire Ave, The Great Room (Room 1503), White Oak Conference Center, Silver Spring, MD, 20903

    Contact:  Susan Monahan Phone: 301-796-5661, E-mail: Susan.Monahan@fda.hhs.gov

    CDRH is exploring the development of a searchable medical device labeling repository that would be accessible by the public and provide useful product information to patients and health care practitioners.

  • Oncologic Drugs Advisory Committee Meeting
    Date:  April 12, 2011
    Time:  8:00 a.m. to 5:00 p.m.
    Location:  FDA White Oak Campus, Building 31, The Great Room (Rm. 1503)
    White Oak Conference Center, 10903 New Hampshire Avenue, Silver Spring, Maryland
    Contact:  Caleb Briggs, Pharm.D., Phone: 301-796-9001, E-mail:
    caleb.briggs@fda.hhs.gov

    During the morning session, the committee will discuss supplemental New Drug Application (sNDA) 022334/S-009, trade name Afinitor (everolimus) tablets, application submitted by Novartis Pharmaceuticals Corporation. The proposed indication (use) for this product is for the treatment of patients with advanced neuroendocrine tumors (NET) of gastrointestinal, lung, or pancreatic origin. During the afternoon session, the committee will discuss sNDA 021938/S-013, trade name Sutent (sunitinib malate) capsules, application submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer Inc. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of unresectable pancreatic neuroendocrine tumors (PNET).

  • Antiviral Drugs Advisory Committee Meeting
    Date:  April 27 and 28, 2011
    Time:  8:00 a.m. to 5:00 p.m.
    Location:  FDA White Oak Campus, Building 31, The Great Room (Rm. 1503)
    White Oak Conference Center, 10903 New Hampshire Avenue, Silver Spring, Maryland
    Contact:  Paul Tran, R.Ph., Phone: 301-796-9001, E-mail:
    paul.tran@fda.hhs.gov

    On April 27, 2011, the committee will discuss a new drug application (NDA) 202-258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

    On April 28, 2011, the committee will discuss a new drug application (NDA) 201-917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

  • Town Hall Discussion With the Director of CDRH and Other Senior Center Management
    Date:  May 5, 2011
    Time:  8:00 a.m. – 12:00 noon EDT
    Location: Sheraton Orlando Downtown Hotel, 400 West Livingston Street
    Orlando, Florida 32801

    Contact:  Susan Monahan Phone: 301-796-5661, E-mail: susan.monahan@fda.hhs.gov

    Following introductions, Dr. Jeffrey Shuren, the Director of CDRH, will describe CDRH’s Strategic Priorities for 2011. Members of the public will then be given the opportunity to present comments to CDRH Senior Staff followed by Q&A session during which any member of the public may ask questions of the CDRH Senior Staff on any topic of interest.

  • Allergenic Products Advisory Committee Meeting
    Date:  May 12, 2011
    Time:  8:00 a.m. to 3:30 p.m.
    Location:  Doubletree Hotel,  8120 Wisconsin Avenue, Bethesda, MD  20814

    Contact:  Gail Dapolito or Jane Brown Phone: 301-827-0314, E-mail:gail.dapolito@fda.hhs.gov; sheryl.clark@fda.hhs.gov

    The committee will receive updates and have discussion on the following topics:  (1) Structure and Activities of the Laboratory of Immunobiochemistry (the Laboratory), Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, FDA; (2) enzyme-linked immunosorbent assay replacement of radial immunodiffusion assays for potency determinations of cat and ragweed pollen allergen extracts by the Laboratory; (3) statistical considerations for the design and interpretation of phase III clinical trials of allergenic products; (4) environmental exposure chambers for phase III studies of allergenic products, and (5) International Organization for Standardization (ISO) 17025 accreditation of the Laboratory.

  • Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee Meeting
    Date:  May 17 and 18, 2011
    Time:  8:00 a.m. to 5:00 p.m. – May 17; 8:00 a.m. to noon – May 18
    Location:  Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Road, Silver Spring, Maryland
    Contact:  Diem-Kieu Ngo, Pharm.D., BCPS Phone: 301-796-9001, E-mail:diem.ngo@fda.hhs.gov

    On May 17 and 18, 2011, the committees will review pertinent pharmacokinetic (how drugs are absorbed, distributed, used, and eliminated by the body), safety and efficacy data, and discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children less than 2 years of age.

  • Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting
    Date:  June 29, 2011
    Time:  8 a.m. to 6 p.m.
    Location:  Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD

    Contact:  Shanika Craig Phone: 301-796-6639

    The committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex.

Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings.  You may also visit this page after meetings to obtain transcripts, presentations, and voting results.  For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.

 

Resources:

  • FDA Patient Safety News
    FDA Patient Safety News is a televised series for health care personnel, carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. It features information on new drugs, biologics and medical devices, on FDA safety notifications and product recalls, and on ways to protect patients when using medical products.
  • FDA Basics
    Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA.

 


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