Amneal gets FDA green light for first generic NuvaRing

Sandra Levy
Senior Editor
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Amneal has received the Food and Drug Administration’s blessing for the first generic of Merck's NuvaRing (etonogestrel/ethinyl estradiol vaginal ring). Amneal's EluRyng is launching immediately.

“We are pleased to announce FDA approval of EluRyng, one of 15 new, complex products we expect to launch over the next 18 to 24 months,” said Chirag and Chintu Patel, co-CEOs. “This milestone underscores Amneal’s deep scientific and regulatory capabilities and our ability to overcome significant barriers to entry, including complex formulation development and specialized manufacturing requirements."

The Patels added, "In addition, EluRyng adds a differentiated, complex dosage form to our portfolio, and bringing this product to market reflects our commitment to improving affordable access to complex drug products. Looking ahead, we remain enthusiastic about the additional high-value opportunities in our pipeline that are designed to improve the lives of patients and drive meaningful growth and value creation for our shareholders and other stakeholders in 2020 and beyond.”

NuvaRing had a market value of roughly $976 million for the 12 months ended Oct. 31, 2019, according to IQVIA.