What's New on the FDA Drugs Site
July 1, 2009
- Early Communication About Safety of Lantus (insulin glargine)
- National Drug Code Directory (updated)
- Public Health Advisory: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban
- Information for Healthcare Professionals: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)
June 29, 2009
- Guidance for Industry: Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs (Level 2 guidance on Penicillin Drugs added)
- Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated)
- Drug Shortages: Resolved Drug Shortages: Metoprolol Succinate extended release tablets (updated)
Visit Drugs@FDA to search Drug Approval Reports by Month.
New and Generic Drug Approvals
July 1, 2009
- Abraxane (paclitaxel) I.V. Suspension, Abraxis BioScience, Inc., Labeling Revision
- Azithromycin Injection, Hospira, Inc., Approval
- Cetirizine Hydrochloride Allergy Tablets, Unichem Laboratories, Ltd., Approval
- Cipro (ciprofloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro (ciprofloxacin) Injection, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro in Dextrose 5% in Plastic Contanier (ciprofloxacin) , Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro (ciprofloxacin) Oral Suspension, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro XR (ciprofloxacin and ciprofloxacin hydrochloride) Extended-Release Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
- Dorzolamide Hydrochloride Ophthalmic Solution, Bausch & Lomb, Inc., Approval
- Finasteride Tablets, Sun Pharmaceutical Industries Ltd., Approval
- Lupron Depot-Ped (leuprolide acetate) Injection, Abbott Laboratories, Labeling Revision
- Montelukast Sodium Chewable Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
- Montelukast Sodium Tablets, Teva Pharmaceuticals, Tentative Approval
- Oxcarbazepine Oral Suspension, Ranbaxy Laboratories Ltd., Approval
- Tev-Tropin (somatropin [rDNA origin] Injection, Ferring Pharmaceuticals, Control Supplement
- Tygacil (tigecycline) I.V. Injection, Wyeth Pharmaceuticals Inc., Package Change
Manage your FDA Subscriptions:
- Update your preferences or unsubscribe
- Questions about this service? support@govdelivery.com
- Other inquiries? webmail@oc.fda.gov
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
0 comments:
Post a Comment