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Lupin Gets US Regulator’s Nod For Vasomotor Drug


New Delhi: Drug firm Lupin has received final approval from the US Food and Drug Administration (FDA) 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 US health regulator, it said in a filing to the BSE.

The company's tablets are a generic version of Amneal Pharmaceuticals' Activella tablets in the same strengths, it added.

As per the IMS MAT March 2016, Activella had US sales of $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.

Shares in Lupin, on Wednesday, ended over 1 per cent higher at Rs 1,464.60 apiece on the BSE, whose benchmark Sensex index finished down 0.18 per cent.

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