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:

• FDA approves imaging agent for central nervous system scans
  The FDA approved Gadavist (gadobutrol), a gadolinium-based contrast agent, for use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system.
  
• FDA approves device to maintain blood flow during artery bypass brain surgery
  The FDA approved a surgical kit that allows neurosurgeons to reroute blood flow around an aneurysm or a tumor in the brains of patients at greater risk of stroke during standard bypass surgery.
  
• FDA approves Benlysta to treat lupus
  The FDA approved Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.
  
• FDA approves new drug to treat chronic obstructive pulmonary disease
  The FDA approved Daliresp (roflumilast), a pill taken daily to decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).

For information on drug approvals, please visit Drugs@FDA

Opportunities for Comment:

• User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
  This guidance provides recommendations to applicants regarding requests for waivers, refunds, 18 and reductions of user fees assessed under sections 735 and 736 of the Federal Food, Drug, and 19 Cosmetic Act (the Act) for drugs, including biological drug products. This guidance is a revision 20 of the draft guidance entitled Draft Interim Guidance Document for Waivers of and Reductions 21 in User Fees (1993 interim guidance), issued July 16, 1993.
  
• Guidance for Industry: Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
  This guidance is intended to encourage manufacturers of medically necessary drug products and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production facilities.

Announcements:

• Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011
  The only over-the-counter asthma inhaler sold in the United States will no longer be available next year as part of an international agreement to stop the use of substances that damage the environment.
  
• Beware of Fraudulent Weight-Loss ‘Dietary Supplements’
  FDA has found weight-loss products tainted with the prescription drug ingredient sibutramine. This ingredient was in an FDA-approved drug called Meridia, which was removed from the market in October 2010 because it caused heart problems and strokes. FDA has also found other prescription drug ingredients that have been removed from the market or never approved at all.
  
• Beware of Fraudulent ‘Dietary Supplements’
  Federal regulators continue to warn consumers about tainted, dangerous products that are marketed as dietary supplements. These fraudulent products can cause serious injury or even death.
  
• FDA, Justice Department take action against McNeil-PPC Inc.
  The FDA announced that a consent decree of permanent injunction has been filed against McNeil-PPC and two of its officers for failing to comply with current good manufacturing practice requirements as required by federal law.
  
• FDA prompts removal of unapproved drugs from market
  The FDA took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States.  Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC).
  
• Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
  Through the Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging,FDA is advocating the universal adoption of two principles of radiation protection: appropriate justification for ordering each procedure, and careful optimization of the radiation dose used during each procedure.

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.