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's CEO and President, Dr. Jack Zhang, commented: "We are excited about the FDA approval of our Ganirelix Acetate Injection. According to IQVIA, the U.S. brand and generic sales for ganirelix acetate injection were approximately $89 million for the 12 months ended December 31, 2021. Amphastar plans to launch its Ganirelix Acetate Injection during the second quarter of 2022.

Source: Forbes April 08, 2022 10:33 UTC