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Noxafil FDA Approval History

FDA Approved: Yes (First approved September 15, 2006)
Brand name: Noxafil
Generic name: posaconazole
Company: Schering-Plough Corporation
Treatment for: Aspergillosis, Invasive, Candidemia, Oral Thrush

Noxafil is a triazole antifungal agent indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

Development Timeline for Noxafil

Mar 14, 2014Approval FDA Approves Merck’s Noxafil (posaconazole) Injection
Nov 26, 2013Approval FDA Approves Merck’s Noxafil Delayed-Release Tablets
Sep 15, 2006Approval Noxafil Schering-Plough Corporation - Treatment for Prevention of Invasive Fungal Infections
Jul 13, 2004Schering-Plough Reports Posaconazole NDA Accepted for FDA Review

Further information

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