Ready-to-Use Phosphorus Solution From Amneal Pharmaceuticals Wins FDA Approval

The FDA has issued a New Drug Application approval for Amneal Pharmaceuticals’ presentation of preservative-free potassium phosphates in 0.9% sodium chloride injection intravenous (IV) ready-to-use bags, the company announced in a release.¹ The phosphorus replacement product is indicated as a source of phosphorus to treat hypophosphatemia in adult and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not suitable.

The new solution simplifies the administration process for health care providers compared to traditional compounded versions. The product is available as a single-dose infusion bag, is formulated without preservatives, is natural rubber latex-free, and can be stored at room temperature.

“We are pleased to offer this new differentiated injectable product to hospitals [and oncology clinics],” said Andy Boyer, executive vice president and chief commercial officer of generics at Amneal Pharmaceuticals, in the release.¹ “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.”

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Already this year, Amneal has launched 2 injectables: Pemrydi RTU, a ready-to-use formulation of pemetrexed, and Focinvez, a ready-to-use version of fosaprepitant. The new FDA-approved presentation will be the company’s third 505(b)(2) injectable added in 2024, expected to launch in the third quarter. Like those before it, the injectable will improve pharmacy efficiency by eliminating preparation steps.

“Our third 505(b)(2) injectable product approval this year reflects our deep capabilities in developing new and impactful complex products,” said Srinivas Kone, MD, senior vice president and chief scientific officer of generics at Amneal Pharmaceuticals, in the same release.¹ “We look forward to bringing more innovative 505(b)(2) injectable products to market over the coming years.”

Adverse effects associated with the potassium phosphates injection IV bags include hyperkalemia, hyperphosphatemia, hypocalcemia and hypomagnesemia.

Hypophosphatemia is a disorder in which there is a low level of phosphate in the blood. Symptoms of the disorder, defined as serum phosphate levels of less than 2.5 mg/dL in adults,² include weakness, trouble breathing, and loss of appetite.

Prior studies have revealed a higher incidence of hypophosphatemia in individuals with chronic health conditions. This is particularly evident in intensive care settings, where as many as 15% of patients are affected.² It is also more pronounced in patients with cancer, as the nature of cancer cells—which require increased phosphate utilization for rapid growth and proliferation—and common cancer treatments often disrupt phosphate homeostasis.³

Amneal Pharmaceuticals’ new presentation provides an additional convenient and effective treatment option for the disorder.

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References

1. Amneal receives US FDA approval for potassium phosphates injection IV bags. News release. Amneal Pharmaceuticals. July 29, 2024. Accessed July 30, 2024. https://investors.amneal.com/news/press-releases/press-release-details/2024/Amneal-Receives-U.S.-FDA-Approval-for-Potassium-Phosphates-Injection-IV-Bags/default.aspx

2. Adhikari S, Mamlouk O, Rondon-Berrios H, Workeneh BT. Hypophosphatemia in cancer patients. Clin Kidney J. 2021;14(11):2304-2315. doi:10.1093/ckj/sfab078

3. Berger MM, Appelberg O, Reintam-Blaser A, et al. Prevalence of hypophosphatemia in the ICU - Results of an international one-day point prevalence survey. Clin Nutr. 2021;40(5):3615-3621. doi:10.1016/j.clnu.2020.12.017