FDA gives Amneal OK for potassium phosphates injection IV bags

The Food and Drug Administration has approved Amneal’s new presentation of potassium phosphates in 0.9% sodium chloride injection intravenous ready-to-use bags. This sterile presentation reduces the compounding steps for clinicians typically required with administering the product, the company said.

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.

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“We are pleased to offer this new differentiated injectable product to hospitals,” said Andy Boyer, executive vice president, chief commercial officer, generics at Amneal. “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 Srinivas Kone, senior vice president, chief scientific officer, generics at Amneal.