Lupin receives US FDA approval for generic Femhrt tabs

The tablets are indicated for the treatment of moderate to severe vasomotor symptoms

Lupin has received final approval for its Fyavolv tablets (norethindrone acetate and ethinyl estradiol tablets usp, 0.5 mg/0.0025 mg and 1 mg/0.005 mg) from the United States Food and Drug Administration (US FDA) 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 US subsidiary, Lupin Pharma 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.