MUMBAI, India — Glenmark Generics Inc. USA, a subsidiary of Glenmark Generics Ltd., has received final approval from the Food and Drug Administration for norethindrone acetate and ethinyl estradiol tablets (0.5 mg/2.5 mcg and 1 mg/5 mcg), a medication for symptoms of menopause.
Glenmark said Tuesday that it will begin distribution of the product, a generic version of Warner Chilcott’s FemHRT, immediately.
Norethindrone acetate and ethinyl estradiol tablets (0.5 mg/2.5 mcg and 1 mg/5 mcg) are used to prevent osteoporosis as well as treat menopausal symptoms such as hot flashes and vaginal dryness, burning, and irritation.
For the 12 months ended this past February, the FemHRT market totaled annual sales of $38.6 million, according to IMS Health data reported by Glenmark.
