Sun Pharma gets US FDA approval for generic Ganirelix Acetate injection

Drug major Sun Pharmaceutical Industries Monday said it has received final approval from US FDA for its abbreviated new drug application (ANDA) for generic version of Ganirelix Acetate injection.

The generic version is therapeutic equivalent to Organon's Ganirelix Acetate injection, 250 mcg/0.5 ml.

Sun Pharma, including its subsidiaries and/or associate companies), announced that Sun Pharma has received final approval from USFDA for its abbreviated new Drug application (ANDA) for 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.

Shares of the company were trading at Rs 453.85, 7.81 per cent lower than its previous closing price.