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Aurobindo Pharma Receives US Regulator's Nod for Generic Drug

Drug firm Aurobindo Pharma has received approval from the US Food and Drug Administration (FDA) to manufacture and market generic Norethindrone Acetate tablets in the American market.
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New Delhi: Drug firm Aurobindo Pharma has received approval from the US Food and Drug Administration (FDA) to manufacture and market generic Norethindrone Acetate tablets in the American market.

The company has received the final nod from the US health regulator to manufacture and market Norethindrone Acetate tablets in the strength of 5 mg, Aurobindo Pharma said in a statement.

"The approved product has an estimated market size of $24 million for the 12 months ending November 2015 according to IMS," it added.

The company's product is generic version of Duramed Pharmaceuticals' Aygestin tablets in the same strength, Aurobindo Pharma said. 

"Norethindrone Acetate tablet is used in the treatment of endometriosis, uterine bleeding caused by abnormal hormone levels and secondary amenorrhea," it added.

The company has a total of 230 abbreviated new drug application (ANDA) approvals (199 final approvals including 10 from Aurolife Pharma LLC and 31 tentative approvals) from FDA.

At 2:24 p.m., shares in Aurobindo Pharma were trading 0.70 per cent lower at Rs 840.20 apiece on the BSE, whose benchmark Sensex index was down 0.04 per cent.

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