Thursday, 20 June 2019

Sun Pharma gets USFDA nod for generic Ganirelix Acetate Injection

03 December 2018 | News

The generic version is therapeutic equivalent to Organon’s Ganirelix Acetate Injection, 250 mcg/0.5 mL

Sun Pharmaceutical Industries Ltd., a generic pharmaceutical company today announced that it has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for a generic version of Ganirelix Acetate Injection, 250 mcg/0.5 mL.

The generic version is therapeutic equivalent to Organon’s Ganirelix Acetate Injection, 250 mcg/0.5 mL.

As per IQVIA, Ganirelix Acetate Injection, 250 mcg/0.5 mL had annual sales of approximately US$ 67 million in the US for the 12 months ended September 2018. The commercialization of this product in the US market is expected in Q4FY19.

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