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Noxafil FDA Approval History

Last updated by Judith Stewart, BPharm on June 2, 2021.

FDA Approved: Yes (First approved September 15, 2006)
Brand name: Noxafil
Generic name: posaconazole
Company: Merck
Treatment for: Fungal Infection Prophylaxis

Noxafil is an azole antifungal indicated as follows:
  • Noxafil is indicated for the 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 (HSCT) recipients with graft-versus host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows:
    • Noxafil injection: adults and pediatric patients 2 years of age and older
    • Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg
    • Noxafil oral suspension: adults and pediatric patients 13 years of age and older
    • Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older (who weigh 40 kg or less)
  • Noxafil oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adult and pediatric patients aged 13 years and older.

Development Timeline for Noxafil

DateArticle
Mar 14, 2014Approval  FDA Approves Merck’s Noxafil (posaconazole) Injection
Nov 26, 2013Approval  FDA Approves Merck’s Noxafil Delayed-Release Tablets
Sep 18, 2006Approval  Schering-Plough Announces FDA Approval of Noxafil (posaconazole) for Prevention of Invasive Fungal Infections
Jul 13, 2004Schering-Plough Reports Posaconazole NDA Accepted for FDA Review

Further information

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