Lupin launches Generic Femhrt in US.

Mumbai, Baltimore, April 18, 2016:

Pharmaceutical Major Lupin Limited (Lupin) announced today that its US subsidiary, Lupin Pharmaceuticals Inc. has launched its FyavolvTM 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 (FDA) 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 FyavolvTM 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 USD 39 million (IMS MAT December 2015).

Press Release