FDA Bids Farewell to Old-School Cancer Drug Tablets
Published Date: 4/10/2026
Notice
Summary
GlaxoSmithKline has stopped selling Wellcovorin tablets and asked the FDA to withdraw its approval for these drugs as of April 10, 2026. This means Wellcovorin tablets (5 mg and 25 mg) can no longer be legally sold or shipped, but pharmacies can use up any leftover stock until it runs out or expires. If needed, GSK can apply again in the future to bring the drug back.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 1 costs, 1 mixed.
Wellcovorin approval withdrawn
The FDA withdrew approval of GlaxoSmithKline's New Drug Application (NDA 018342) for Wellcovorin (leucovorin calcium) tablets, EQ 5 mg and EQ 25 mg, effective April 10, 2026. After that date, introducing or delivering these products into interstate commerce without an approved NDA violates the Federal Food, Drug, and Cosmetic Act.
Existing stock may still be dispensed
Any Wellcovorin (leucovorin calcium) tablets, EQ 5 mg and EQ 25 mg, that were in inventory on April 10, 2026 may continue to be dispensed until inventories are depleted, the products reach their expiration dates, or otherwise become violative—whichever comes first.
Withdrawal without prejudice to refiling
The FDA's withdrawal of approval is 'without prejudice' to refiling, meaning GlaxoSmithKline may apply in the future to seek approval again for Wellcovorin (NDA 018342).
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Take It Personal
Get Your Personalized Policy View
Start a Free Government Policy Watch to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in