FDA Extends Coral Snake Antivenin Lot CL6814 Expiration to June 2026 on Stability Data

With no licensed alternative available in the U.S., FDA has extended the expiration date of North American Coral Snake Antivenin Lot CL6814 by one year, to June 30, 2026, relying on stability and potency data to justify continued distribution of a product whose label still carries a 2022 manufacture date.

The product, Antivenin (Micrurus fulvius) (Equine Origin), was manufactured by Wyeth Pharmaceuticals, now a wholly owned subsidiary of Pfizer, and is the sole U.S.-licensed treatment for envenomation by the Eastern and Texas Coral Snake. The previous expiration date of June 30, 2025, has been superseded following FDA's evaluation of stability data confirming the lot retains adequate potency for an additional twelve months. For QA directors and regulatory leads managing biologics inventory, the extension underscores how stability-driven shelf-life determinations can function as a supply continuity mechanism when no replacement product exists.

The regulatory pathway here is instructive. FDA's decision rests on lot-specific stability data rather than a labeling change at the manufacturer level, meaning the physical label on Lot CL6814 continues to display 06/2022 as the assigned expiration. Facilities holding this lot should ensure their inventory management systems and dispensing records reflect the agency-authorized date of June 30, 2026, not the printed label, to remain aligned with current regulatory status and avoid unnecessary product destruction.

For biologics manufacturers navigating comparable supply constraints, the CL6814 extension illustrates the evidentiary standard FDA applies: demonstrated maintenance of stability and potency against pre-established specifications, evaluated on a lot-by-lot basis. Teams managing aging biological inventory under 21 CFR Part 600 should treat this case as a reference point for the data package required to support a shelf-life extension request, particularly where no licensed substitute product exists and public health considerations are explicit.

The authorized use period for Lot CL6814 now runs through June 30, 2026, a checkpoint that supply chain and QA teams at facilities stocking this antivenin should build into their expiry monitoring and CAPA review cycles.

Source: FDA Vaccines, Blood & Biologics Safety and Availability Communications via FDA.gov RSS Feed, October 26, 2026.