Determination That Romidepsin Injection, 10 Milligrams/2 Milliliters (5 Milligrams/Milliliter) and 27.5 Milligrams/5.5 Milliliters (5 Milligrams/Milliliter), Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) has determined that Romidepsin Injection, 10 milligrams (mg)/2 milliliters (mL) (5 mg/mL) and 27.5 mg/5.5 mL (5 mg/mL), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for romidepsin solution, 10 mg/2 mL (5 mg/mL) and 27.5 mg/5.5 mL (5 mg/mL), that refer to these drugs as long as they meet relevant legal and regulatory requirements.