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Aurobindo Pharma Ltd has received approval from the US Food and Drug Administration (USFDA) to manufacture and market Norethindrone Acetate tablets.
The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product Aygestin of Duramed Pharmaceuticals.
It is used in the treatment of endometrosis, uterine bleeding caused by abnormal hormone levels and secondary amenorrhea, the Hyderabad-based company said in a release.
The approved product has an estimated market size of $24 million for the 12 months ended November 2015, according to IMS.
Aurobindo’s scrip was trading down 1 per cent at Rs 837.70 on the Bombay Stock Exchange.
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