AMRX - Amneal wins FDA nod for generic version of Ortho Evra

Amneal Pharmaceuticals (AMRX) is surging with a ~6.3% gain in the pre-market today after its Q4 2020 earnings came ahead of analyst expectations.The company also announced the FDA approval for its Abbreviated New Drug Application ("ANDA") for Norelgestromin and Ethinyl Estradiol Transdermal system, a generic version of the reference listed drug (“RLD”) Ortho Evra.Drug comes with a boxed warning regarding cigarette smoking and serious cardiovascular events and contraindicated for use in women over 35 years old who smoke and those with a BMI more than 30 kg/m2.Amneal expects to begin its commercialization from March 01 under the proprietary name Zafemy.While Ortho Evra has been discontinued, Xulane which raked in ~$332M for the manufacturer Mylan in 2020 is the only other equivalent to Ortho Evra® currently available on the market, according to the company.Aiming to challenge Ortho Evra marketed by JNJ, Mylan (NASDAQ:MYL) in 2014 launched its generic equivalent Xulane.

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Amneal wins FDA nod for generic version of Ortho Evra