Aurobindo Pharma gets FDA nod for new drug

Product has estimated market size of $24 mn for 12 months to Nov 2015; firm now has 230 ANDA approvals

Hyderabad-based Aurobindo Pharma Limited 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 drug product Aygestin tablets 5 mg of US-based Duramed Pharmaceuticals, the company said in a filing to the BSE on Monday.

Norethindrone Acetate tablet is indicated for the treatment of endometriosis, 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 2015.

Aurobindo said this was 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 scrip is currently trading at Rs 838.55 on the BSE, down 0.90 per cent, over the previous close of Rs 846.15.