The tablets 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 Generics Inc USA, a subsidiary of Glenmark Generics, has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) 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.
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. 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. For the 12 month period ending February 2015, the FemHRT market garnered annual sales of $38.6 million according to IMS Health.
Glenmark’s current portfolio consists of 96 products authorised 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.
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