FDA approves abbreviated new drug application for ganirelix acetate injection

Amphastar Pharmaceuticals received FDA approval of its abbreviated new drug application for ganirelix acetate injection for use in inhibiting luteinizing hormone surges in controlled ovarian stimulation, according to a press release.

The FDA determined the 250 mg/0.5 mL injection, which comes in a prefilled syringe, is biologically and therapeutically equivalent to Organon Pharmaceuticals’ ganirelix acetate injection.

“We are excited about the FDA approval of our ganirelix acetate injection,” Jack Y. Zhang, PhD, CEO and president of Amphastar, said in the release. “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.”

The company anticipates launching the ganirelix acetate injection in the second quarter of 2022.