Glenmark Generics claimed that it is currently the only Indian company to be granted an abbreviated new drug application (ANDA) approval or an oral contraceptive product.
Glenmark Generics said that Northindrone tablets are a progestin-only oral contraceptive indicated for the prevention of pregnancy.
Terrance Coughlin, CEO of Glenmark Generics Limited, said: “This is a milestone in the evolving history of Glenmark Generics. Heather represents our first launch of an oral contraceptive in the US and the first FDA approval on a product out of our hormone facility located in Goa, India.”
Reportedly, Glenmark Generics already has existing ANDAs pending approval with the FDA along with additional products in various stages of development within this oral contraceptive therapeutic segment.