Amneal Pharmaceuticals Inc (NYSE: AMRX) is flying for the top in the market this morning, gaining more than 30% early on after announcing FDA approval. Here’s what’s going on:
AMRX Stock Flies On FDA Approval
In a press release issued early this morning, Amneal Pharmaceuticals said that it has received an approval from the United States Food and Drug Administration. The approval surrounds the company’s Abbreviated New Drug Application with regard to EluRyng.
EluRyng is the first generic version of NuvaRing. Importantly, the company has already initiated commercial activities for the product. In fact, EluRyng is being manufactured eternally and will be launched immediately.
In a statement, Chirag and Chintu Patel, Co-CEOs at AMRX, had the following to offer:
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. 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.
What This Means For The Company
The news released today is incredibly positive for AMRX and its investors. There are multiple reasons for the excitement today. Here’s how I see it:
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