- The FDA has approved Amphastar Pharmaceuticals Inc's (NASDAQ:AMPH) Abbreviated New Drug Application for Ganirelix Acetate Injection, 250mg/0.5mL in a prefilled syringe.
- Ganirelix acetate injection is indicated to inhibit premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.
- The FDA determined Amphastar's ganirelix is bioequivalent and therapeutically equivalent to Organon & Co's (NYSE:OGN) 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.
- The Company currently has four ANDAs on file with the FDA targeting products with a market size of approximately $3.9 billion, three biosimilar products in development targeting products with a market size of roughly $13 billion, and eight generic products in development targeting products with a market size of approximately $12 billion.
- Price Action: AMPH shares are down 0.11% at $40.12 during the premarket session on the last check Friday.
