Lupin gets USFDA nod for generic Amabelz tablets

Drug firm Lupin has received final approval from the US health regulator for its generic Amabelz tablets in the American market.
The company has received "final approval for its Amabelz tablets (Estradiol and Norethindrone Acetate tablets USP, 0.5 mg / 0.1 mg and 1 mg / 0.5 mg) from the United States Food and Drug Administration (FDA)," Lupin said in a filing to BSE.
The company's tablets are generic version of Amneal Pharmaceuticals' Activella tablets in the same strengths, it added.
As per IMS MAT March 2016, Activella had US sales of USD 95.6 million, Lupin said.
The tablets are used for treatment of moderate to severe vasomotor symptoms due to menopause and prevention of post-menopausal osteoporosis.

Mumbai-based Lupin produces and develops a wide range of branded and generic formulations, biotechnology products and APIs globally.
Lupin stock closed over 1 per cent up at Rs 1,464.60 per on BSE.