Amneal Gets U.S. FDA Green Light for Potassium Phosphates Injection IV Bags

On July 29, 2024, Amneal Pharmaceuticals, Inc. announced that it has obtained New Drug Application (NDA) approval from the U.S. Food and Drug Administration (FDA) for its new formulation of potassium phosphates in 0.9% sodium chloride injection intravenous (IV) ready-to-use (RTU) bags. This sterile presentation minimizes the compounding steps usually needed by clinicians when administering the product.

Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product used to address hypophosphatemia in adults and pediatric patients weighing 40 kg or more when oral or enteral replacement is not feasible, insufficient, or contraindicated. The product comes in a single-dose infusion bag, is preservative-free, and does not contain natural rubber latex. It can be stored at room temperature.

In 2024, Amneal has launched PEMRYDI RTU®, a ready-to-use formulation of pemetrexed, and FOCINVEZ®, a ready-to-use version of fosaprepitant. These products provide hospitals and oncology clinics with new, value-added options that enhance pharmacy efficiency by eliminating preparation steps. The anticipated launch of the potassium phosphates injection IV bag in the third quarter will mark the company’s third 505(b)(2) product launch of the year.

“We are excited to provide this new, differentiated injectable product to hospitals,” said Andy Boyer, Executive Vice President and Chief Commercial Officer of Generics. “This preservative-free IV parenteral infusion bag can be stored at room temperature. The introduction of this new 505(b)(2) injectable significantly expands our injectables portfolio.”

“Our third 505(b)(2) injectable product approval this year highlights our strong capabilities in developing innovative and impactful complex products,” said Dr. Srinivas Kone, Senior Vice President and Chief Scientific Officer of Generics. “We are eager to introduce more groundbreaking 505(b)(2) injectable products to the market in the years ahead.”

Reported adverse effects for the potassium phosphates injection IV bags include hyperkalemia, hyperphosphatemia, hypocalcemia, and hypomagnesemia.

Amneal Pharmaceuticals, Inc., based in Bridgewater, NJ, is a global pharmaceutical company dedicated to making health possible through the development, manufacturing, and distribution of over 280 diverse pharmaceutical products, primarily within the United States. The Generics segment is broadening its reach across various complex product categories and therapeutic areas, including injectables and biosimilars. The Specialty segment boasts an expanding portfolio of branded pharmaceuticals targeting central nervous system and endocrine disorders, with a pipeline designed to address unmet needs. Additionally, the AvKARE segment distributes pharmaceuticals and other products to the U.S. federal government, as well as retail and institutional markets. Amneal Pharmaceuticals’ extensive portfolio of over 280 generic and specialty pharmaceuticals forms the foundation for making health possible.