24 Sep 2025
💊FDA Approves Previously Withdrawn NDA for Wellcovorin Tablets
Approval of Previously Withdrawn New Drug Application for WELLCOVORIN (Leucovorin Calcium) Tablets
Summary
The Food and Drug Administration (FDA or Agency) is announcing approval of the previously withdrawn new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets, equivalent to (EQ) 5 milligrams (mg) base and EQ 25 mg base. FDA is initiating this action on the basis of new data and is required to publish notice of approval of an NDA for which the Agency had previously withdrawn approval.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The approval of Wellcovorin (leucovorin calcium) tablets creates a market opportunity for businesses in the pharmaceutical industry. The new data on its efficacy for treating cerebral folate deficiency may lead to increased demand and necessitate potential compliance adjustments for manufacturers.