FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT RASUVO (METHOTREXATE) SOLUTION, 27.5 MILLIGRAMS/0.55 MILLILITER (27.5 MILLIGRAMS/0.55 MILLILITER), WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, July 22 -- Food and Drug Administration has issued a notice called: Determination That RASUVO (Methotrexate) Solution, 27.5 Milligrams/0.55 Milliliter (27.5 Milligrams/0.55 Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on July 22 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) has determined that RASUVO (methotrexate) solution, 27.5 milligrams (mg)/0.55 milliliter (mL) (27.5 mg/0.55 mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs)...