Amneal Pharmaceuticals Gets Additional FDA New Drug Application Approval - News Summed Up

Amneal Pharmaceuticals Gets Additional FDA New Drug Application Approval


By Sabela OjeaAmneal Pharmaceuticals said the U.S. Food and Drug Administration approved its new drug application for its potassium phosphates in sodium chloride injection, available as a single-dose infusion bag. The pharmaceutical company on Monday said that the injection is a phosphorus replacement product indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients when oral or replacement is not possible, insufficient or contraindicated. The symptoms of hypophosphatemia, a disorder in which there is a low level of phosphate in the blood, include weakness, trouble breathing and loss of appetite. Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix(END) Dow Jones NewswiresJuly 29, 2024 16:38 ET (20:38 GMT)Copyright (c) 2024 Dow Jones & Company, Inc.


Source: Wall Street Journal July 29, 2024 20:42 UTC



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