BackAurobindo gets FDA nod to sell norethindrone acetate tablets in US
Drug is used in the treatment of endometrosis, uterine bleeding caused by abnormal hormone levels and secondary amenorrhea
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Hyderabad: Aurobindo Pharma Ltd on Monday said it has won US Food and Drug Administration approval to make and sell Norethindrone Acetate tablets (5mg) in the US.
The approved Abbreviated New Drug Application (ANDA) is the bio-equivalent of Aygestin from Duramed Pharmaceuticals. It is used in the treatment of endometrosis, uterine bleeding caused by abnormal hormone levels and secondary amenorrhea, the company said in a release.
Duramed is part of Israel-based Teva Pharmaceutical Industries Ltd.
The approved product had an estimated market size of $24 million for the 12 months ending November 2015, according to US-based health care information provider IMS Health.
Aurobindo now has a total of 230 ANDA approvals, including 199 final approvals and 31 tentative approvals from the US regulator.
Shares of Aurobindo closed down 1.40% at ₹ 834.30 on BSE, while the benchmark Sensex was down 0.44% at 24,825.04 points.
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