Glenmark's oral contraceptive gets FDA nod


Glenmark's US subsidiary Glenmark Generics has been granted approval by the United States Food and Drug Administration (FDA) for Norethindrone tablets 0.35mg—its generic version of Nor-QD. The product will be marketed under the trade name Heather and distribution is expected to start immediately.

With this approval, Glenmark becomes the only Indian company to be granted an ANDA approval on an oral contraceptive product. The US contraceptive market has historically been the largest of the seven major markets with sales reaching $4.5 billion in the 12 month period ending December 2009.

Terrance Coughlin, CEO, Glenmark Generics said, "This is a milestone in the evolving history of Glenmark Generics. Heather represents our first launch of an oral contraceptive in the United States and the first FDA approval on a product out of our hormone facility located in Goa, India"

Glenmark already has existing abbreviated new drug applications (ANDAs) pending approval with the US FDA along with additional products in various stages of development within this oral contraceptive therapeutic segment.
© BioSpectrum Bureau

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