UpDate: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 20 Aug 2008 08:26:12 -0500 (CDT)
Subject: FDA Warning Letters Update
You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
UpDate: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 20 Aug 2008 14:02:46 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 8/20/2008
UpDate: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 20 Aug 2008 15:13:23 -0500 (CDT)
Subject: CDER New 8/20/2008
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August 20, 2008
- The Prescription Drug User Fee Act (PDUFA) News: The FY 2009 Product and Establishment Fee Invoices were mailed Friday, August 15, 2008. Full payment of the invoice is due by October 1, 2008. If you do not receive your invoice by August 25, 2008, please contact Michael Jones or Beverly Friedman at 301-796-3602.
- Generic Drug Petition Tracking: Suitability Tracking Reports (updated)
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 20 Aug 2008 20:03:03 -0500 (CDT)
Subject: Enforcement Report for August 20, 2008
Enforcement Report for August 20, 2008
Wed, 20 Aug 2008 17:49:00 -0500
Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
UpDate: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 20 Aug 2008 14:57:07 -0500 (CDT)
Subject: FDA Information Update for Health Professionals - August 20, 2008
U.S. Food and Drug Administration
Office of Special Health Issues
5600 Fishers Lane, HF-12
Rockville, Maryland 20857
Dear Colleague,
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety information, product approvals, and upcoming meetings. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY INFORMATION:
Byetta (exenatide) (August 18)
[UPDATED 08/18/2008] Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.
Boston Scientific NexStent Monorail NexStent Carotid Stent and Monorail Delivery System (August 14)
Boston Scientific and FDA informed healthcare professionals and patients of the Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008. The device is used in patients to treat a blockage in carotid artery disease. The product was recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure.
Information for Healthcare Professionals on Naltrexone Injection Site Reactions (August 12)
FDA ALERT [08/12/2008]: FDA is notifying healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone (Vivitrol). Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening injection site reactions to a surgeon.
Information for Health Professionals on Simvastatin used with Amiodarone (August 8)
FDA ALERT [08/08/2008]: The FDA is notifying the public of the risk of a rare condition of muscle injury called rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone.
On August 7, 2008, Amgen and Ortho Biotech announced the EPOGEN®/PROCRIT® (Epoetin alfa) and Aranesp® (darbepoetin alfa) labeling were revised to strengthen the safety information for healthcare professionals and patients.
PRODUCT APPROVALS:
FDA Approves First Drug for Treatment of Chorea in Huntington's Disease (August 15)
The U.S. Food and Drug Administration has approved Xenazine (tetrabenazine) for the treatment of chorea in people with Huntington's disease. Chorea is the jerky, involuntary movement that occurs in people with this disease. Xenazine is a new drug and is the first treatment of any kind approved in the United States for any symptom of Huntington's disease. Currently there are no other drugs that are FDA-approved to treat chorea.
For more information on product approvals, please visit Approvals of FDA-Regulated Products.
ANNOUNCEMENTS
FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies (August 8)
Expired and suspected counterfeit prescription drugs found at pharmacies
The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.
The FDA is recruiting for 1,300 medical and science positions to strengthen the agency's public health mission. The FDA has been granted "direct hire" authority to fill these positions quickly with qualified applicants. For dates and schedules for job fairs, please visit FDA's Nationwide Job Fairs.
UPCOMING MEETINGS:
2008 PDA/FDA Joint Regulatory Conference
DATE: September 8-10, 2008
LOCATION: Renaissance Hotel, 999 9th Street NW, Washington, D.C. 20001
CONTACT: Leslie Edmonds, Coordinator, Programs and Meetings, edmonds@pda.org or (301) 656-5900 ext. 160.
FDA Nanotechnology Public Meeting
DATE: September 8, 2008, 8:30 a.m.
LOCATION: University Systems of Maryland, The Universities at Shady Grove Conference Center, 9630 Gudelsky Drive, Rockville, MD
CONTACT: Email nanotech@fda.hhs.gov or call 301-827-3360.
Reproductive Health Drugs Advisory Committee
DATE: September 9, 2008, 8:00 a.m.
LOCATION: Hilton Washington DC Rockville, Plaza Ballrooms I and II, 1750 Rockville Pike, Rockville, MD
CONTACT: Kalyani Bhatt, 301–827–7001.
Blood Products Advisory Committee
DATE AND TIME: September 10-11, 8:00 a.m.
LOCATION: Hilton Hotel, Washington, DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852
CONTACT: Donald W. Jehn or Pearline K. Muckelvene, 301-827-0314.
For notice of advisory committee meetings posted on earlier Health Professional communications additional information can be found after the meeting has been held. For information such as presentations, transcripts and voting results, please see FDA's Advisory Committee page.
RESOURCES:
The FDA the Week: Andy's Take (August 15, 2008)
Commissioner for Food and Drugs Andrew von Eschenbach discusses weekly FDA issues of interest to the American consumer and occasionally preview upcoming FDA issues and events. Featured this week is "BPA: The Science, Evaluation and Safety."
Health Professionals Website (August 2008)
FDA recently launched a new Health Professionals web page as part of a larger effort by the agency to increase interactions and communications with health professional organizations. The webpage provides useful, timely, and accessible information to the nation's physicians, nurses, pharmacists, and other members of the health professional team.
If you have any questions, you may send an email to webmail@oc.fda.gov or contact us at the numbers listed below.
Sincerely,
Janelle Derbis, PharmD
312-596-6516 (Chicago)
Brenda L. Evelyn, SBB(ASCP)
Brenda.evelyn@.fda.hhs.gov
301-827-4460
Heidi Marchand, PharmD
301-827-4460
