Aurobindo Pharma Limited said it received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Norethindrone Acetate Tablets USP, 5mg.
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 US$ 24 million for the twelve months ending November 2015 according to IMS, it said.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Aygestin Tablets, 5 mg, of Duramed Pharmaceuticals.
This is the 57th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India 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 USFDA.
Headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients.
The company’s product portfolio is spread over 6 major therapeutic areas such as Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergies, supported by an outstanding R&D set-up.
It sells in over 150 countries.