Withdrawal of Approval for Wellcovorin (Leucovorin Calcium) Tablets
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The FDA is withdrawing its approval for Wellcovorin (leucovorin calcium) tablets by GlaxoSmithKline because the drugs are no longer marketed. Pharmacies can continue selling existing inventory until it is used up or becomes expired, whichever comes first.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Withdrawal of FDA approval for Wellcovorin tablets.
- Existing stocks can be dispensed until depleted or expired.
- Selling these tablets without approval is illegal after withdrawal.
Obligations
What this law requires
Cease introduction or delivery of Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base, into interstate commerce without an approved NDA as of April 10, 2026
Pharmacies and distributors may continue dispensing existing Wellcovorin (leucovorin calcium) tablets inventory until depletion, expiration date, or product becomes violative, whichever occurs first
GlaxoSmithKline must not introduce or deliver Wellcovorin (leucovorin calcium) tablets into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act after approval withdrawal on April 10, 2026