Amneal Pharmaceuticals, Inc. announced that it has received New Drug Application (“NDA”) approval from the U.S. Food and Drug Administration (FDA) for its new presentation of potassium phosphates in 0.9% sodium chloride injection intravenous (IV) ready-to-use (RTU) bags. This sterile presentation reduces the compounding steps for clinicians typically required with administering the product.
Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient or contraindicated. The product is available as a single-dose infusion bag and is formulated without preservatives. It is natural rubber latex-free 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 offer hospitals and oncology clinics new, value-added presentations that should improve pharmacy efficiency by eliminating preparation steps. The expected third quarter launch of potassium phosphates injection IV bag represents the Company’s third 505(b)(2) launch this year.
“We are pleased to offer this new differentiated injectable product to hospitals,” said Andy Boyer, Executive Vice President, Chief Commercial Officer – Generics. “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,” said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Generics.
SOURCE: Businesswire