Amphastar receives FDA approval for Ganirelix Acetate injection

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’s CEO and President, Dr Jack Zhang, commented: “We are excited about the FDA approval of our Ganirelix Acetate injection. Ganirelix is the Company’s fourth injectable peptide product approval. It represents our capabilities in executing our pipeline while furthering the development of our diabetes product portfolio.”

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.

Pipeline information
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 approximately $13 billion, and eight generic products in development targeting products with market size of approximately $12 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2021. The Company is developing multiple proprietary products with injectable and intranasal dosage forms.

Amphastar’s Chinese subsidiary, ANP, currently has 17 Drug Master Files, or DMFs, on file with the FDA and is developing several additional DMFs. Accesswire