Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (FDA) to manufacture and market norethindrone acetate 5 mg tablet, a generic version of Duramed Pharmaceuticals’ Aygestin tablet.
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, India for manufacturing oral non-antibiotic products.
