Amneal's Potassium Phosphates Injection IV Bags Set To Transform IV Therapy

Amneal Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for a new formulation of potassium phosphates in 0.9% sodium chloride injection, available in ready-to-use (RTU) intravenous (IV) bags. This new sterile presentation streamlines the administration process for clinicians by minimizing compounding requirements.This potassium phosphates product serves as a phosphorus replacement for treating hypophosphatemia in adults and pediatric patients weighing 40 kg or more when oral or enteral replacement isn't feasible or is contraindicated. It is offered as a single-dose infusion bag, free from preservatives and natural rubber latex, and can be stored at room temperature.

In 2024, Amneal has already launched PEMRYDI RTU®, a ready-to-use formulation of pemetrexed, and FOCINVEZ®, a ready-to-use version of fosaprepitant. Both products enhance pharmacy efficiency by removing preparation steps, and the anticipated launch of the potassium phosphates IV bag in the third quarter marks Amneal's third 505(b)(2) product release this year.Andy Boyer, Executive Vice President, Chief Commercial Officer at Generics, said, “We are pleased to offer this new differentiated injectable product to hospitals. This new IV parenteral infusion bag is preservative-free and can be stored at room temperature. With the addition of new 505(b)(2) injectables, we are meaningfully expanding our injectables portfolio.”

"Our third 505(b)(2) injectable product approval this year reflects our deep capabilities in developing new and impactful complex products. We look forward to bringing more innovative 505(b)(2) injectable products to market over the coming years," stated Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer at Generics.