FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT LEUCOVORIN CALCIUM, ORAL SOLUTION, EQUIVALENT TO 60 MILLIGRAMS BASE/VIAL, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, May 8 -- Food and Drug Administration has issued a notice called: Determination That Leucovorin Calcium, Oral Solution, Equivalent to 60 Milligrams Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on May 8 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) has determined that leucovorin calcium, oral solution, equivalent to (EQ) 60 milligrams (mg) base/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for leucovorin calcium, oral solution, EQ ...