Glenmark gets USFDA nod for osteoporosis drugs

The approved formulations are generic versions of Warner Chilcott's FemHRT, which clocked sales of $39 mn for year ended Feb 2015

Glenmark Pharmaceuticals today said it has received the final approval from the United States Food and Drug Administration (USFDA) for sale of drugs meant to prevent post-menopause osteoporosis.

The approval for sale of Norethindrone Acetate and Ethinyl Estradiol tablets was given to Glenmark Generics Inc USA, a subsidiary of Glenmark Generics Ltd.

Glenmark Generics Inc USA has been "...Granted final abbreviated new drug approval (ANDA) from the USFDA for Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/2.5 mcg and 1 mg/5 mcg. Glenmark will commence distribution of the product immediately," Glenmark said in a BSE filing.

Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/2.5 mcg and 1 mg/5 mcg are Glenmark's generic version of Warner Chilcott's FemHRT, it added.

"Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/2.5 mcg and 1 mg/5 mcg 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," the firm said.

For the 12 month period ending February 2015, the FemHRT market garnered annual sales of $38.6 million according to IMS Health, Glenmark added in the filing.

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.

Shares of Glenmark Pharmaceuticals at 1140 hours were trading at Rs 854 apiece, up by 0.71 per cent from its previous BSE closing.