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Amneal has received FDA approval for its generic of Ortho Evra (150 mcg/day Norelgestromin and 35 mcg/day ethinyl estradiol transdermal system), a contraceptive patch that it will market under the proprietary name Zafemy.
The company also was granted a competitive generic therapy designation for the product, giving it 180 days of market exclusivity. Amnealexpects to begin commercialization activities on March 1, 2021. Though Ortho Evra was discontinued by the manufacturer, Mylan s Xulane has thus far been the only equivalent available until now.
“Today’s approval is a significant milestone for patients and our company,” Amneal co-CEOs Chirag and Chintu Patel said in a statement. “Zafemy will provide patients with another option to the one equivalent product Xulane, manufactured by Mylan currently on the market. It also demonstrates the continued successful execution of our strategy to develop and commercialize complex generics and represen
Amneal Pharmaceuticals, Inc (AMRX) Q4 2020 Earnings Call Transcript
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