Lupin Ltd has received final approval for its Fyavolv tablets (Norethindrone Acetate and Ethinyl Estradio tablets USP, 0.5 mg/0.0025 mg and 1 mg/0.005 mg) from the US FDA to market 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 US subsidiary, Lupin Pharmace Uticals Inc. shall commence promoting the product in the US shortly.
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 USD 39.9 million, according to IMS MAT September 2015 data.