Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) announced today that it has received New Drug Application (NDA) approval from the U.S. Food and Drug Administration (FDA) for its new potassium phosphates in 0.9% sodium chloride IV bags. This new ready-to-use (RTU) sterile presentation streamlines the administration process by eliminating compounding steps for clinicians.
“This preservative-free IV infusion bag can be stored at room temperature, enhancing convenience for hospitals. This launch marks a significant expansion of our injectables portfolio,” said Andy Boyer, Executive Vice President and Chief Commercial Officer – Generics.
Potassium Phosphates in Sodium Chloride Injection is designed to correct hypophosphatemia in adults and pediatric patients weighing 40 kg or more, when oral or enteral replacement is not viable. The product comes in a single-dose, preservative-free infusion bag that is also natural rubber latex-free.
Earlier in 2024, Amneal introduced PEMRYDI RTU®, a ready-to-use formulation of pemetrexed, and FOCINVEZ®, a ready-to-use version of fosaprepitant, enhancing pharmacy efficiency by removing preparation steps. The potassium phosphates IV bag will be Amneal’s third 505(b)(2) injectable product launch of the year.
Dr. Srinivas Kone, Senior Vice President and Chief Scientific Officer – Generics, stated, “This approval highlights our capability to develop impactful complex products. We look forward to introducing more innovative 505(b)(2) injectables in the future.”
Adverse effects of the potassium phosphates IV bags include hyperkalemia, hyperphosphatemia, hypocalcemia, and hypomagnesemia. For full prescribing information, see the package insert.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), based in Bridgewater, NJ, is a global pharmaceutical company. We offer a diverse portfolio of over 280 products, focusing on both generics and specialty pharmaceuticals. Our Generics segment includes a range of complex products and biosimilars, while our Specialty segment focuses on CNS and endocrine disorders. Through AvKARE, we also distribute pharmaceuticals to the U.S. federal government and other markets.
