Merck announces FDA approval for Noxafil Merck announced that the FDA has approved NOXAFIL injection, a new formulation of NOXAFIL for intravenous use. Merck’s antifungal agent is also marketed as NOXAFIL delayed-release tablets and NOXAFIL oral suspension. NOXAFIL injection, delayed-release tablets and oral suspension are indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy. With this approval, Merck now provides an IV formulation and two oral formulations of NOXAFIL for prophylaxis against invasive Aspergillus and Candida infections in high-risk patients.
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FDA approves Belsomra sleep drug The Food and Drug Administration approved Belsomra tablets for use as needed to treat difficulty in falling and staying asleep. Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Belsomra will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information. Belsomra is a controlled substance because it can be abused or lead to dependence. Belsomra is made by Merck, Sharpe & Dohme.