Lupin gains on USFDA nod for generic Femhrt tablets

The approval is for dosages of 0.5mg and 1mg tablets

Shares of Lupin were up over 1% on the Bombay Stock Exchange after the pharma major said it has received final approval for its Fyavolv tablets from the US Food & Drug Administration to market generic version of Warner Chilcott's Femhrt tablets(Norethindrone Acetate and Ethinyl Estrabiol tablets USP, 0.5mg/0.0025mg and 1mg/0.005 mg).

The tablets are dispensed for the treatment of moderate to severe vasomotor symptoms due to menopause and prevention of post menopausal osteoporosis, the company said in a release.

Lupin’s US subsidiary, Lupin Pharmaceuticals Inc. shall commence promoting the product in the US shortly, the release added.