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June 7, 2021Noxafil Receives Expanded Indication and New Dosage Form
June 4, 2021 – The U.S. FDA has approved expanded indications for Merck Sharp & Dohme Corp’s Noxafil® (posaconazole) intravenous (IV) injection and Noxafil delayed-release oral tablets. Noxafil is approved for prophylaxis of invasive Aspergillus and Candida infections in severely immunocompromised individuals at high risk of developing these infections. Under the expanded indications:
- Noxafil IV injection is indicated for use in adult and pediatric patients at least two years of age. Previously, this dosage form was indicated for use only in adults; and
- Noxafil delayed-release tablets are indicated for use in adult and pediatric patients who are at least two years old and weigh more than 40kg (88 pounds).
The FDA has also approved a new dosage form. Noxafil is now available as a powder for delayed-release oral suspension, which is indicated for use in pediatric patients who are at least two years old and weigh less than 40kg.
Both a type of fungus, Aspergillus and Candida are present in the environment and usually don’t cause illness. However, individuals whose immune systems have been compromised (for instance by graft- versus-host disease or chemotherapy) are at increased risk. Medication for prophylaxis can help prevent fungal infections from developing.
Noxafil first received FDA approval in 2006 and is also indicated to treat a type of fungal throat infection known as oropharyngeal candidiasis. Recommended dosing is based on the indication and the dosage form being used.