Amneal Gets FDA Nod for Potassium Phosphates IV Bags

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) has announced that the U.S. Food and Drug Administration (FDA) has approved their New Drug Application (NDA) for potassium phosphates in 0.9% sodium chloride injection in intravenous (IV) ready-to-use (RTU) bags. This product aims to simplify the administration process for clinicians by reducing the usual compounding steps.

The new potassium phosphates in sodium chloride injection is designed to replenish phosphorus levels in adults and children weighing 40 kg or more who cannot take oral or enteral phosphorus or when such routes are inadequate or contraindicated. This single-dose infusion bag is preservative-free, latex-free, and can be stored at room temperature, enhancing its practicality for clinical use.

In 2024, Amneal has already introduced PEMRYDI RTU®, a ready-to-use form of pemetrexed, and FOCINVEZ®, a ready-to-use version of fosaprepitant. These products aim to enhance efficiency in hospitals and oncology clinics by eliminating the need for preparation steps. The expected launch of the potassium phosphates injection IV bag in the third quarter represents Amneal's third 505(b)(2) product release this year.

“We are pleased to offer this new differentiated injectable product to hospitals,” said Andy Boyer, Executive Vice President, Chief Commercial Officer of Generics at Amneal. He highlighted that the product is preservative-free, can be stored at room temperature, and adds significant value to their injectables portfolio.

Dr. Srinivas Kone, Senior Vice President and Chief Scientific Officer of Generics at Amneal, stated that this third 505(b)(2) injectable product approval in a year underscores the company's robust capabilities in developing complex new products. He expressed optimism about bringing more innovative 505(b)(2) injectable products to the market in the future.

However, there are adverse effects associated with the potassium phosphates injection IV bags, such as hyperkalemia, hyperphosphatemia, hypocalcemia, and hypomagnesemia. Detailed prescribing information can be found in the product's package insert.

Amneal Pharmaceuticals, Inc., headquartered in Bridgewater, NJ, is a global pharmaceutical firm engaged in developing, manufacturing, and distributing a diverse array of over 280 pharmaceutical products, primarily within the U.S. The company’s Generics segment is expanding into various complex product categories and therapeutic areas, including injectables and biosimilars. The Specialty segment focuses on branded pharmaceuticals mainly targeting central nervous system and endocrine disorders. The AvKARE segment distributes pharmaceuticals and other products to the U.S. federal government, as well as retail and institutional markets.