Lupin receives USFDA approval for generic Femhrt Tablets

Lupin has received final approval for its Fyavolv Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/0.0025 mg and 1 mg/0.005 mg) from the United States Food and Drug Administration (USFDA) to market a generic version of Warner Chilcott’s Femhrt Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/0.0025 mg and 1 mg/0.005 mg). The pharma major’s US subsidiary, Lupin Pharmaceuticals Inc. shall commence promoting the product in the US shortly.

Lupin’s Fyavolv Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/0.0025 mg and 1 mg/0.005 mg) are the AB rated generic equivalent of Warner Chilcott’s Femhrt Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/0.0025 mg and 1 mg/0.005 mg). It is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis. Femhrt had US sales of $39.9 million, as per IMS MAT September 2015.

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.