Aurobindo Pharma gets FDA nod for new drug

The 5 mg Norethindrone Acetate USP tablet, used to treat endometriosis and secondary amenorrhea, has a market size of $24 million for the 12 months ending November 2016

Hyderabad-based Aurobindo Pharma Limited on Monday said it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Norethindrone Acetate tablets USP in 5 mg strengths.

The approved abbreviated new drug application (ANDA) is bioequivalent and therapeutically-equivalent to the reference-listed 5 mg Aygestin tablets made by US-based Duramed Pharmaceuticals, the company said in a filing to the Bombay Stock Exchange. 

Norethindrone Acetate tablet is used to treat 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.

Aurobindo Pharma Limited's shares are currently trading at Rs 838.55 apiece on the BSE, down 0.90% over their previous close of Rs 846.15.