Amphastar's Generic Ganirelix Acetate Injection Scores FDA Approval

The FDA has approved Amphastar Pharmaceuticals Inc's 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 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.