Changeflow GovPing Pharma & Drug Safety FDA Extends Coral Snake Antivenin Expiration Date
Routine Notice Amended Final

FDA Extends Coral Snake Antivenin Expiration Date

Favicon for www.fda.gov FDA CBER Biologics Safety Communications
Published June 30th, 2026
Detected March 24th, 2026
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Summary

The FDA has extended the expiration date for Lot CL6814 of Antivenin (Micrurus fulvius) (Equine Origin), commonly known as North American Coral Snake Antivenin, from June 30, 2025, to June 30, 2026. This extension is based on stability data indicating the lot will maintain potency for an additional year.

What changed

The FDA has extended the expiration date for a specific lot (CL6814) of North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) from June 30, 2025, to June 30, 2026. This decision was made after evaluating stability data which confirmed the lot's continued potency. The antivenin is used to treat envenomation by Eastern and Texas Coral Snakes and is the only licensed product available in the U.S. for this purpose.

Healthcare providers administering this antivenin should be aware of the extended expiration date for Lot CL6814. While the product is labeled with an earlier expiration date of 06/2022, the FDA's extension to June 30, 2026, permits its use beyond the original printed date. This information is critical for ensuring the availability of effective treatment for coral snake bites.

What to do next

  1. Update internal inventory and administration records to reflect the extended expiration date of June 30, 2026, for Antivenin Lot CL6814.
  2. Ensure all clinical staff are informed of the extended expiration date for this specific lot of North American Coral Snake Antivenin.

Source document (simplified)


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).

Coral Snake Antivenom product was manufactured by Wyeth Pharmaceuticals, now a wholly owned subsidiary of Pfizer, Inc.  FDA has extended the expiration date on this Lot CL6814 of Antivenin (Micrurus fulvius) (Equine Origin), from June 30, 2025, to June 30, 2026.  The extension is based upon FDA evaluation of stability data, which determined that this lot will maintain stability and potency for an additional year after the previously approved expiration date of June 30, 2025.
There is no alternative product licensed in the U.S. for coral snake envenomation. Lot CL6814 is labeled with an expiration date of 06/2022, which was assigned at the time of manufacture.

  • ## Content current as of:

03/23/2026

  • Regulated Product(s)

    • Biologics

Classification

Agency
FDA
Published
June 30th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Public health authorities
Industry sector
6211 Healthcare Providers 3254 Pharmaceutical Manufacturing
Activity scope
Biologics Administration
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Pharmaceuticals Product Safety

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