Quality & complianceOfficial

FDA extends expiry of coral snake antivenin Lot CL6814 to end of 2026

🇺🇸 FDA CBER · Mon 26 Oct 2026

CBER has pushed the expiry of the only US-licensed coral snake antivenin lot from 30 June to 31 December 2026, citing stability data.

The US Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has extended the expiration date of Lot CL6814 of Antivenin (Micrurus fulvius) (Equine Origin), commonly known as North American Coral Snake Antivenin. The new date is 31 December 2026, replacing the previously approved date of 30 June 2026.

CBER said the decision rests on its evaluation of stability data. According to the agency, those data show the lot will keep its stability and potency for six months beyond the earlier expiry date.

The antivenin is indicated for envenomation by the Eastern coral snake (Micrurus fulvius fulvius) and the Texas coral snake (Micrurus fulvius tenere). The product was made by Wyeth Pharmaceuticals, now a wholly owned subsidiary of Pfizer. FDA states that no alternative product is licensed in the US for coral snake envenomation.

The agency also notes that Lot CL6814 carries a labelled expiry of 06/2022, assigned at manufacture. The extension therefore differs from the printed date on the packaging. The notice appears on CBER's 2026 safety and availability communications page and was listed as current as of 1 July 2026.

What it means for your team

  • Quality and inventory teams holding Lot CL6814 should update expiry records to reflect 31 December 2026, while recognising that the label still reads 06/2022.
  • Storage and use decisions for this lot should follow the FDA extension notice rather than the printed expiry date.
  • Pharmacovigilance and supply teams should note that no US-licensed alternative exists, so availability of this lot is clinically significant.
  • The extension is limited to Lot CL6814 and is time-bound; teams should track the new end date.

Official source: FDA CBER ↗

Article written by VigiEye from the official source (FDA CBER). AI-assisted; check the source before acting.

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