FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: GLAXOSMITHKLINE; WITHDRAWAL OF APPROVAL OF A NEW DRUG APPLICATION FOR WELLCOVORIN (LEUCOVORIN CALCIUM) TABLETS, EQ 5 MG BASE AND EQ 25 MG BASE

WASHINGTON, April 10 -- Food and Drug Administration has issued a notice called: GlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (Leucovorin Calcium) Tablets, EQ 5 mg Base and EQ 25 mg Base.

The notice was published in the Federal Register on April 10 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base, held by GlaxoSmithKline, LLC, 2020 Walnut Street, Philadelphia, PA 19104 (GSK). GSK notified the Agency in writing that the drug products were no longer marketed and requested th...