Sun Pharmaceutical Industries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for 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.