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Aurobindo Pharma Ltd gets FDA nod for new drug
Aurobindo Pharma Ltd has announced the receipt of final approval from the US Food and Drug Administration (USFDA) to manufacture and market Norethindrone Acetate tablets in 5 mg strengths.
Hyderabad: Aurobindo Pharma Ltd has announced the receipt of final approval from the US Food and Drug Administration (USFDA) to manufacture and market Norethindrone Acetate tablets in 5 mg strengths. The drug is bioequivalent and therapeutically-equivalent of Aygestin tablets made by US-based Duramed Pharmaceuticals, the company said in a filing.
The drug is used in the treatment of endometriosis, or uterine bleeding caused by abnormal hormone levels and secondary amenorrhea. The approved product has an estimated market size of $24 million for the 12 months ending November 2016.
Aurobindo said this is the 57th ANDA to be approved out of its VII unit formulation plant in Hyderabad for manufacturing oral non-antibiotic products. The company now has 230 ANDA approvals, it added.
