PITTSBURGH — Mylan on Friday announced that its partner Famy Care has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol tablets USP in the 0.15mg/0.03mg strength.
The product is a generic version of Teva Branded Pharmaceutical Products' Nordette 28 Tablets, a form of oral contraception. The new product will be distributed in the United States by Mylan Pharmaceuticals, and the company is shipping the product immediately.
Mylan currently has 34 oral contraceptives pending approval with the FDA and expects to receive additional approvals within next year's first quarter, said Heather Bresch, Mylan CEO.
Levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg, had U.S. sales of approximately $60.4 million for the 12 months ended Sept. 30, 2012, according to IMS Health.