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news.Glenmark Generics, USA, a subsidiary of Glenmark Generics Limited, has been granted approval by the FDA for Northindrone tablets 0.35mg, their generic version of Nor-QD. The product is expected to be marketed under the trade name Heather and the distribution of the product will soon be started, said the company.
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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.