Famy Care has won final FDA approval for abbreviated new drug application (ANDA) of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15mg/0.03mg, generic equivalent to Teva Branded Pharmaceutical Products' Nordette 28 tablets.
Mylan Pharmaceuticals will distribute the product, which is indicated for the prevention of pregnancy in women, in the US.
Mylan CEO Heather Bresch said, "The approval and immediate launch of our Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, represents an exciting advance for the women's health care franchise that Mylan is establishing in partnership with Famy Care Ltd., one of the world's largest manufacturers of oral contraceptives."
According to IMS Health, Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15mg/0.0 mg had total sales of approximately $60.4m in the US for the year ending 30 September 2012.
