Global pharma major Lupin Limited recently announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Ganirelix Acetate Injection, 250 mcg/0.5 mL Single-Dose Prefilled Syringe.
The approval to market a generic equivalent to the reference listed drug (RLD), of Ganirelix Acetate Injection, 250 mcg/0.5 mL of Organon USA LLC. Ganirelix is Lupin’s first peptide-based injectable, strengthening the Company’s commitment to innovative healthcare solutions.
The product will be manufactured at Lupin’s Nagpur facility in India.
Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.
Ganirelix Acetate Injection had estimated annual sales of USD 84 million in the U.S. (IQVIA MAT September 2023).
