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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 Origin)

 

Important Notification
 
This is to provide you with important information regarding Antivenin (Micrurus fulvius) (Equine Origin), commonly referred to as North American Coral Snake Antivenin.  Antivenin (Micrurus fulvius) (Equine Origin) 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 for lot 4030024 of Antivenin (Micrurus fulvius) (Equine Origin).  The extension is based upon FDA evaluation of stability data, which determined that this lot of product will maintain stability and potency through April 30, 2014. 
 
Wyeth Pharmaceuticals no longer manufactures Antivenin (Micrurus fulvius) (Equine Origin). There is no alternative product licensed in the U.S. for coral snake envenomation.
 
As of now, there are two lots of Antivenin (Micrurus fulvius) (Equine Origin) available for distribution. 
 
  • Lot 4030024, with a new expiration date of April 30, 2014.  Because this lot has a new expiration date, you may maintain the product in your inventory and keep it available for use until April 30, 2014.    The manufacturer is updating the expiration date through a Dear Health Care Provider Letter
  • Lot 4030026, with an expiration date of October 31, 2013. This lot continues to be available in limited quantities. 
 
Reintroduction of lot 4030024 will enhance supply continuity for Antivenin (Micrurus fulvius) (Equine Origin). Wyeth is closely managing their inventory, and will supply product only to direct customers.