Amphastar Pharmaceuticals, Inc.,announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Abbreviated New Drug Application (“ANDA”) for Ganirelix Acetate Injection, 250mg/0.5mL in a prefilled syringe. Ganirelix acetate injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation. The FDA determined Amphastar’s ganirelix is bioequivalent and therapeutically equivalent to Organon Pharmaceuticals’ Ganirelix Acetate Injection.
Amphastar is a biopharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products. Most of the Company’s finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. Read more here.