You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).
Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 28 May 2008 06:15:11 -0500 (CDT)
Subject: CDRH New Update
 | Date: May 28, 2008 |
The following new items were added to the CDRH web pages on May 27, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Transcripts |  |
| Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Other | |
| Summary Information for: Zenith® TX2®® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System | |  |
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 28 May 2008 08:27:02 -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.
Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 28 May 2008 13:06:38 -0500 (CDT)
Subject: FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding
FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding
Wed, 28 May 2008 13:00:00 -0500
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 28 May 2008 14:46:03 -0500 (CDT)
Subject: FDA Update for Health Professionals - May 28, 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:
FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding (May 28)
The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.
Today FDA held a stakeholder briefing on this topic. A replay of the teleconference will be available starting at 11:00 a.m. EDT today through June 6, 2008. To hear the replay, callers in the United States can dial 866-490-5921; international callers 203-369-1708.
FDA Requests Recall of Xiadafil VIP Tabs (May 27)
On May 27, 2008, the FDA requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. These lots of Xiadafil VIP Tabs bear an expiration date of September 2009 (09/09). Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and able to treat erectile dysfunction (ED).
FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream - Product can be harmful to nursing infants (May 23)
On May 23, 2008, the FDA warned consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Product labeling specifically states that there is no need for mothers to remove the cream prior to nursing. However, the ingredients contained in the product may be harmful to nursing infants.
Information for Healthcare Professionals Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic) (May 16)
On May 16, 2008, FDA announced the agency was aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy. In most cases, the mothers were taking MMF following an organ transplant to prevent organ rejection. However, some mothers taking MMF were being treated for immune-mediated conditions such as systemic lupus erythematosus (SLE) and erythema multiforme. FDA is continuing to work with the manufacturers of these drug products to develop and implement means to mitigate the risks of fetal exposure.
Medicis Announces Voluntary Recall of Solodyn® (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up (May 16)
On May 16, 2008, Medicis announced that the Company is voluntarily recalling several lots of SOLODYN® 90 mg Tablets, Extended Release. Medicis has received a report that one bottle in lot number B080037 contains AZASAN® (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN® (minocycline HCl, USP) Extended Release Tablets, 90 mg. AZASAN® is an immuno-suppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking AZASAN® instead of SOLODYN® presents a health hazard and safety risk to patients.
Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 16)
On May 16, 2008, Hydrox Labs, Elgin, IL issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. As a result of this recall, Cardinal Health is initiating a voluntary sub recall of this lot of alcohol-free mouthwash. The mouthwash was tested, and certain samples were found positive for Burkholderia cepacia (B. cepacia). Product was distributed to hospitals, medical centers, and long term care facilities nationwide.
FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. (May 16)
The announced on May 16, 2008, that Scientific Laboratories Inc., its president, and chief executive officer have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with the law and obtain approval for their products.
The unapproved new drugs manufactured and marketed by Scientific Laboratories as prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. Because these drugs have not undergone FDA review nor received approval, their safety and effectiveness have not been established.
Johnson and Johnson Recalled Certain Lots of Drug Products After Theft (May 15)
On May 15, 2008, Johnson & Johnson announced it was voluntarily recalling specific lots of Procrit, Remicade, and Doxil to protect patients from receiving potentially mishandled or damaged products after a truck carrying the products was stolen.
PRODUCT APPROVALS:
FDA Approves Entereg to Help Restore Bowel Function Following Surgery (May 20)
The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.
For additional information on product approvals, please visit Approvals of FDA-Regulated Products
ANNOUNCEMENTS
New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care (May 22)
On May 22, 2008, HHS Secretary Mike Leavitt announced efforts underway at the FDA and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. In a white paper released by the FDA, the agency describes plans for the Sentinel Initiative, which will include the development of a new electronic system that will enable FDA to query a broad array of information to identify possible post-market adverse events. That Sentinel System will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort.
A press teleconference was held on May 22 for credentialed media. If you are interested in listening to the teleconference, a replay will be available starting at 3:30 p.m. EDT through June 5. To hear the replay, callers in the United States can dial 800-801-6154; international callers can dial 1-402-280-1615.
For additional information, please visit FDA's Sentinel Initiative.
FDA's Hiring Initiative
The Food and Drug Administration 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:
Dermatologic and Ophthalmic Drugs Advisory Committee
DATE AND TIME: May 29, 8:00 a.m.
LOCATION: Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD
CONTACT: Yvette Waples, Center for Drug Evaluation and Research, 301-827-7001. More Information
Science Board to the Food and Drug Administration
DATE AND TIME: May 30, 8:00 a.m.
LOCATION: Washington DC North/Gaithersburg Hilton, 620 Perry Pkwy., Gaithersburg, MD 20877, Salons A, B, and C.
CONTACT: Carlos Pena, Office of the Commissioner, 301-827-6687. More Information
Oncologic Drugs Advisory Committee
DATE AND TIME: May 30, 8:00 a.m.
LOCATION: Hyatt Regency McCormick Place, Regency Ballroom, 2233 South Martin L. King Dr. , Chicago, IL.
CONTACT: Nicole Vesely, Center for Drug Evaluation and Research, 301-827-6793. More Information
Meeting for Public Comment on the Pilot Program to Evaluate Proposed Name Submissions
DATE AND TIME: June 5-6, 2008, 8:30 a.m. - 5:00 p.m.
LOCATION: Crowne Plaza Hotel, 877 Georgia Ave., Silver Spring, MD
CONTACT: Lana Pauls, Center for Drug Evaluation and Research, 301-796-0518
More Information
Pediatric Ethics Subcommittee of the Pediatric Advisory Committee
DATE AND TIME: June 9-10, 8:30 a.m.
LOCATION: Holiday Inn /Gaithersburg, The Ballroom, Two Montgomery Village Ave., Gaithersburg, MD
CONTACT: Carlos Pena, Office of the Commissioner, 301-827-3340. On June 9, 2008. More Information
Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee
DATE AND TIME: June 12, 8:00 a.m.
LOCATION: Hilton Washington DC North/Gaithersburg, Salons A, B, & C, 620 Perry Pkwy., Gaithersburg, MD
CONTACT: Neel J. Patel, Center for Devices and Radiological Health, 240-276-3700. More Information
Dermatologic and Ophthalmic Drugs Advisory Committee
DATE AND TIME: June 17-18, 8:00 a.m.
LOCATION: Food and Drug Administration, Center for Drug Evaluation and Research, Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD
CONTACT: Yvette Waples or John Lauttman, Center for Drug Evaluation and Research, 301-827-7001. More Information
Anti-Infective Drugs Advisory Committee
DATE AND TIME: July 16, 8:00 a.m.
LOCATION: Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD
CONTACT: Sohail Mosaddegh, Center for Drug Evaluation and Research, 301-827-7001. More Information
RESOURCES:
FDA Consumer Health Information page contains articles you may wish to use in your newsletter or link to from your organization's Web site. For this article and additional timely content, visit the Consumer Health Information page.
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
Janelle.derbis@fda.hhs.gov
312-596-6516 (Chicago)
Brenda L. Evelyn, SBB(ASCP)
Brenda.evelyn@.fda.hhs.gov
301-827-4460
Heidi Marchand, PharmD
Heidi.marchand@fda.hhs.gov
301-827-4460
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
