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Aurobindo Pharma gets US FDA approval for norethindrone acetate tabs

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The tablets are used in the treatment of endometriosis, uterine bleeding caused by abnormal hormone levels, and secondary amenorrhea

Aurobindo Pharma has received the final approval from the US Food & Drug Administration (US FDA) to manufacture and market Norethindrone Acetate tablets USP, 5mg. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Aygestin tablets, 5 mg, of Duramed Pharmaceuticals.

Norethindrone acetate tablet is used in 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 twelve months ending November 2015 according to IMS.

This is the 57th ANDA to be approved out of Unit VII formulation facility in Hyderabad for
manufacturing oral non-antibiotic products. Aurobindo now has a total of 230 ANDA approvals (199 final approvals including 10 from Aurolife Pharma LLC and 31 Tentative approvals) from US FDA.

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