Merck drug approved for preventing fungal infections in immunosuppressed patients

FDA approves Noxafil delayed-release tablets

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a new tablet form of an antifungal drug made by Merck, the company said Tuesday.

Merck announced the FDA approval of Noxafil (posaconazole) 100-mg delayed release tablets. The company also markets a 40-mg-per-milliliter oral suspension form of the drug. The new tablet formulation is designed to be taken in two 300-mg doses on the first day, followed by a 300-mg dose once per day.

The drug is approved for preventing invasive Aspergillus and Candida fungus infections in patients aged 13 and older who are at high risk of developing them due to depressed immune function resulting from hematopoietic stem cell transplants and low white blood cell counts caused by chemotherapy, a condition known as neutropenia.


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