Zdrowie i gospodarka · 3.11.2017
Determination That REVEX (Nalmefene Hydrochloride Injection), 0.1 Milligram Base/Milliliter and 1.0 Milligram Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that REVEX (nalmefene hydrochloride injection), 0.1 milligram (mg) base/milliliter (mL) and 1.0 mg base/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, if all other legal and regulatory requirements are met.