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 (US FDA) to market a generic version of Warner Chilcott Company’s Ovcon 35 tablets (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4mg/0.035 mg). Lupin’s US subsidiary Lupin Pharmaceuticals 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, Ovcon 35 tablets had an annual US sales of approximately $22.3 million (IMS MAT Mar 2013).
EP News Bureau – Mumbai
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