Lupin receives USFDA approval for Oral Contraceptive Vyfemla tablets

Lupin has received final approval for its Vyfemla tablets (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4mg/0.035 mg) from the United States Food and Drugs Administration (USFDA) to market a generic version of Warner Chilcott Company, LLC.’s Ovcon 35 Tablets (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4mg/0.035 mg). Lupin’s US subsidiary Lupin Pharmaceuticals Inc (LPI) shall commence marketing the product shortly.

Lupin's Vyfemla Tablets (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg) is the AB rated generic equivalent of Warner Chilcott's Ovcon 35 Tablets and is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Warner Chilcott Company, LLC’s Ovcon 35 Tablets had annual U.S sales of approximately US$ 22.3 million (IMS MAT Mar 2013).

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs globally.