Glenmark receives US FDA approval for FemHRT generic

The US Food and Drug Administration (US FDA) has granted final abbreviated new drug approval (ANDA) for Glenmark Generics’ 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, said the company in a press release.
 
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. 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.