Glenmark receives US FDA approval for norethindrone acetate and ethinyl estradiol tablets USP

  • Posted on: 9 April 2015
  • By: admin

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Glenmark Generics Inc. USA, a subsidiary of Glenmark Generics, has received the final approval from the United States Food and Drug Administration (USFDA) for sale of drugs meant to prevent post-menopause osteoporosis.USFDA granted Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/2.5 mcg and 1 mg/5 mcg.

Norethindrone acetate and ethinyl estradiol tablets, which are Glenmark’s generic version of Warner Chilcott’s FemHRT are indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis in women at significant risk of osteoporosis. Glenmark will commence distribution of the product immediately. For the 12 month period ending February 2015, the FemHRT market earned annual sales of $38.6 million.

Glenmark’s current portfolio include  96 products authorized for distribution in the US marketplace and 69 ANDA’s pending approval with the US FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals and aims to be a global integrated generic and API leader. It supplies APIs to customers in approximately 80 countries, including the US, various countries in the EU, South America and India.


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