NEW DELHI: Through a recent press release the drug major Sun Pharma said it has received final approval from USFDA for its abbreviated new drug application (ANDA) for a generic version of Ganirelix Acetate injection.
Ganirelix Acetate Injection (ganirelix) is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH).
The generic version is therapeutic equivalent to Organon’s Ganirelix Acetate injection, 250 mcg/0.5 ml.
Sun Pharma, including its subsidiaries and/or associated companies, announced that Sun Pharma has received final approval from USFDA for its abbreviated new Drug application (ANDA) for a generic version of Ganirelix Acetate injection, 250 mcg/0.5 ml, the company said in a regulatory filing.
As per IQVIA, Ganirelix Acetate injection, 250 mcg/0.5 ml had annual sales of approximately $67 million in the US for the 12 months ended September 2018, the company said.
The commercialisation of this product in the US market is expected in Q4FY19, it added.
Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States.