Aurobindo Pharma receives US FDA Approval for Norethindrone Acetate Tablets

Aurobindo Pharma Limited today said  it has received final approval from the US Food & Drug Administration to manufacture and market Norethindrone Acetate Tablets USP, in 5mg dosage.

This is Aurobindo Pharma's 57th ANDA to be approved out of formulation facility in Hyderabad, for manufacturing oral non-antibiotic products.

"The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Aygestin Tablets, 5 mg, of Duramed Pharmaceuticals," Aurobindo Pharma said in a statement.

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 12 months ending November 2015 according to IMS.

Aurobindo now has a total of 230 ANDA approvals (199 Final approvals including 10 from Aurolife Pharma LLC and 31 Tentative approvals) from USFDA.