Amneal Receives Abbreviated New Drug Application Approval for EluRyng, the First Generic NuvaRing

Amneal Pharmaceuticals announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for EluRyng (etonogestrel/ethinyl estradiol vaginal ring), the first generic version of NuvaRing. Amneal has initiated commercialization activities for EluRyng, which is being manufactured internally and launching today.

“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-Chief Executive Officers. “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. 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.”

According to IQVIA, a leading healthcare data and analytics provider, NuvaRing U.S. annual sales for the 12 months ended October 31, 2019 were approximately $976 million.