USFDA approves Sun Pharma’s generic version of Organon’s infertility drug

Sun Pharma, a renowned drug manufacturer on Monday said that it had received final approval from the USFDA for the new drug application abbreviated as ANDA, which is the generic version of Ganirelix Acetate Injection, 250 mcg/0.5 mL.

This version shares its effects with Organon’s Ganirelix Acetate Injection, 250 mcg/0.5 mL, and is a therapeutic equivalent. It is used to treat infertility.

The drug is an injectable competitive gonadotropin-releasing hormone antagonist. With the primary use of controlled ovulation, it is used in effective reproduction.

Ganirelix Acetate Injection comes as a colorless, terile, ready-to-use aqueous solution meant for SUBCUTANEOUS administration only. Each sterile, prefilled syringe contains 250 mcg/0.5 mL of Ganirelix Acetate, 0.1 mg glacial acetic acid, 23.5 mg mannitol, and water for injection adjusted to pH 5.0 with acetic acid, NF and/or sodium hydroxide, NF.

As per IQVIA, the annual sales of Ganirelix Acetate Injection, 250 mcg/0.5 mL was approximately $67 million in the United States for 12 months ended September 2018.

The product is expected to be commercialized in the US market by Q4FY19.

The shares of Sun Pharma were down 9.64 per cent and were trading at Rs 444.85 on BSE at 9.34, while the benchmark Sensex gained 0.39 percent to 36,333.65.