Pharma major Lupin Ltd on Friday said it has received approval from the U.S. health regulator to market its generic Ganirelix Acetate injection used for hormone response regulation in women undergoing treatment for infertility.
The approval by the U.S. Food and Drug Administration is for the abbreviated new drug application for Ganirelix Acetate injection of strength 250 mcg/0.5 mL single-dose prefilled syringe, Lupin said in a regulatory filing.
The injection is a generic equivalent to the reference listed drug Ganirelix Acetate Injection in strength of 250 mcg/0.5 mL of Organon USA LLC.
The product will be manufactured at Lupin's Nagpur facility in India, it added.
Ganirelix Acetate injection had estimated annual sales of $84 million in the U.S., Lupin said citing IQVIA MAT September 2023 data.
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