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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine) Lot 4030026 Through October 31, 2012

Important Notification

This is to provide you with important information regarding Antivenin (Micrurus fulvius) (Equine), commonly referred to as North American Coral Snake Antivenin.  Antivenin (Micrurus fulvius) (Equine) is indicated for treatment of envenomation by Micrurus fulvius fulvius (Eastern Coral Snake) and Micrurus fulvius tenere (Texas Coral Snake).  This product was manufactured by Wyeth Pharmaceuticals, now a wholly owned subsidiary of Pfizer, Inc.

FDA has extended the expiration date on this lot of Antivenin (Micrurus fulvius) (Equine).  The extension is based upon FDA evaluation of stability data, which determined that this lot of product will maintain stability and potency for an additional year. 

Wyeth Pharmaceuticals no longer manufactures Antivenin (Micrurus fulvius) (Equine).  There is no alternative product licensed in the U.S. for coral snake envenomations. Lot 4030026 is labeled with an expiration date of October 31, 2008.   Because this lot has a new expiration date, you may continue to maintain the product in your inventory and keep it available for use until October 31, 2012.    The manufacturer is updating the current labeling through a Dear Health Care Provider Letter

Lot 4030026 continues to be available.  Wyeth is closely managing their inventory, and will supply product only to direct customers.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002