Lupin's US subsidiary -- Lupin Pharmaceuticals Inc. has launched its Fyavolv Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/0.0025 mg and 1 mg/0.005 mg) having received an approval from the United States Food and Drug Administration (USFDA) earlier 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).
Lupin's Fyavolv Tablets are the AB rated generic equivalent of Warner Chilcott's Femhrt Tablets. 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 million, as per IMS MAT December 2015.
Lupin is an India-based transnational pharmaceutical company. The Company is engaged in the producing, developing and marketing of branded and generic formulations, and active pharmaceutical ingredients (APIs). 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.
