Subject: CDER New 3/13/2008
| ||||||||||||
March 13, 2008
- New and Generic Drug Approvals
- Minocycline Hydrochloride Capsules, Aurobindo Pharma, Approval
- Monurol (fosfomycin tromethamine) Zambon, Labeling Revision
- Paclitaxel Injection, PLIVA, Approval
- Septra (sulfamethoxazole; trimethoprim) Tablets, and Septra DS (sulfamethoxazole; trimethoprim) Tablets, Monarch Pharms, Labeling Revision
- Septra (sulfamethoxazole; trimethoprim) Suspension, Monarch Pharms, Labeling Revision
- Septra (sulfamethoxazole; trimethoprim) I.V., Monarch Pharms, Labeling Revision
- Tobramycin (tobramycin sulfate) Injection, Akorn-Strides, Approval
- Tussionex Pennkinetic (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension, UCB Inc., Labeling Revision
- Urex (methenamine hippurate) Oral Tablets, Vatring Pharms, Labeling Revision
- Urso Forte (ursodiol, USP) Tablets, Axcan Scandipharm, Package Change
- VFEND (voriconazole) Tablets, Pfizer Inc., Labeling Revision
- VFEND (voriconazole) I.V. for Injection, Pfizer Inc., Labeling Revision
- VFEND (voriconazole) for Oral Suspension, Pfizer Inc., Labeling Revision
- Amgen and FDA notify healthcare professionals of changes to the Boxed Warnings/Warnings for increased mortality and/or tumor progression section of the Aranesp and Epogen/Procrit labeling. MedWatch Information
- Approved Drug Products with Therapeutic Equivalence Evaluations: Orange Book
- Dissolution Methods Database (updated)
- Drug Approval Reports
- NDA and BLA Approvals (updated)
- NME Drug and New Biologic Approvals (updated)
- Priority NDA and BLA Approvals (updated)
- FDA and Tibotec Therapeutics notify healthcare professionals of changes to the Warnings section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. MedWatch Information
Update : 2
Subject: Slade Gorton and Co. Recalls Icybay Cooked Langostinos Because of Possible Health Risk (March 14)
Slade Gorton and Co. Recalls Icybay Cooked Langostinos Because of Possible Health Risk (March 14)
Fri, 14 Mar 2008 12:48:00 -0500
The product retails in one pound, clear plastic package marked with UPC 0-73129-61672-8 on the top and with an expiration date of June 2009 and is distributed under the brand name of "ICYBAY". The product also was distributed to wholesale accounts, also under the "ICYBAY" brand, in five pound clear plastic packages containing either 70-90 count, 90-125 count or 120-150 count. This recall involves production dates of July 18, 2007 through August 13, 2007 and/or Julian dates of 199 through 232.
Update : 3
Subject: FDA 101: Medication Errors
FDA 101: Medication Errors
Fri, 14 Mar 2008 13:08:00 -0500
There have been adverse events and deaths in children and adults due to the misuse of Tussionex, a long-acting prescription cough medicine. Learn more about this and other medication errors that have been reported to FDA.
Update : 4
Subject: FDA Takes Next Step in Establishing Overseas Presence
FDA Takes Next Step in Establishing Overseas Presence
Fri, 14 Mar 2008 18:00:00 -0500
In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.
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
