Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 22 Apr 2008 08:34:43 -0500 (CDT)
Subject: CDER New 4/21/2008
| ||||||||||||
April 21, 2008
- CDER updates Information on Adverse Event Reports and Heparin
- FDA issues a map of Countries with Contaminated Heparin API
- FDA/DIA co-sponsored conference: Emerging Regulatory Issues in Genomic Medicine, May 21-23, Mexico City, Mexico. Meeting information and registration
- New and Generic Drug Approvals
- AUGMENTIN ES-600 (amoxicillin, clavulanate potassium) Powder for Oral Suspension, GlaxoSmithKline, Labeling Revision
- AUGMENTIN XR (amoxicillin, clavulanate potassium) Extended Release Tablets, GlaxoSmithKline, Labeling Revision
- COPEGUS (ribavirin) Tablets, Roche, Labeling Revision
- Crixivan (indinavir sulfate) Capsules, Merck & Co., Labeling Revision
- Cyclobenzaprine Hydrochloride Tablets, Amneal Pharma, Approval
- Felodipine Extended-release Tablets, Mylan Pharma, Approval
- Metformin Hydrochloride Extended-Release Tablets, NeuroSci Inc., Approval
- Oxacillin (oxacillin sodium) Injection, Baxter Healthcare, Labeling Revision
- Synthroid (levothyroxine sodium) Tablets, Abbott Labs, Labeling Revision
- Timentin in Plastic Container (ticarcillin disodium, clavulanate potassium) Injection, GlaxoSmithKline, Labeling Revision
- Timentin (ticarcillin disodium, clavulanate potassium) Injection, GlaxoSmithKline, Labeling Revision
- Zosyn (piperacillin sodium, tazobactam sodium) Injection, Wyeth Pharma, Labeling Revision
- Zosyn in Plastic Container (piperacillin sodium, tazobactam sodium) Injection, Wyeth Pharma, Labeling Revision
- Warning Letter: Inspection; Changzhou SPL Company, Ltd.
- Warning Letter: Viagra
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 22 Apr 2008 13:05:25 -0500 (CDT)
Subject: FDA Approves Cimzia to Treat Crohn's Disease
FDA Approves Cimzia to Treat Crohn's Disease
Tue, 22 Apr 2008 12:25:00 -0500
A new drug has been approved to help sufferers of Crohn's disease, the U.S. Food and Drug Administration announced today. Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn's disease who have not responded to conventional therapies.
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 22 Apr 2008 13:05:29 -0500 (CDT)
Subject: Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Dried Snow Fungus (April 8)
Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Dried Snow Fungus (April 8)
Tue, 22 Apr 2008 12:14:00 -0500
Fine Land Corp, 239 Bay 20th Street Brooklyn NY 11214, is recalling its Ying Feng Foodstuffs brand dried snow fungus because it contains undeclared sulfites.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 22 Apr 2008 13:07:36 -0500 (CDT)
Subject: Fine Land Corp Issues Alert on Undeclared Sulfites in Golden Girl Brand "Mut Gung" Sweetened Ginger (April 8)
Fine Land Corp Issues Alert on Undeclared Sulfites in Golden Girl Brand "Mut Gung" Sweetened Ginger (April 8)
Tue, 22 Apr 2008 12:14:00 -0500
Fine Land Corp, 239 Bay 20th Street, Brooklyn, NY 11214 is recalling its Golden Girl brand "Mut Gung" sweetened ginger because it contains undeclared sulfites.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 22 Apr 2008 13:08:06 -0500 (CDT)
Subject: Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Dried Bulbus Lily (April 11)
Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Dried Bulbus Lily (April 11)
Tue, 22 Apr 2008 12:14:00 -0500
Fine Land Corp, 239 Bay 20th Street Brooklyn NY 11214, is recalling its Ying Feng Foodstuffs brand Dried Bulbus Lily because it contains undeclared sulfites.
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
