Expanded use for antifungal OK'd
A little more than a month after the drug's initial approval, posaconazole oral suspension (Noxafil, Schering-Plough) has received a second regulatory green light. The antifungal can now be used for the treatment of oropharyngeal candidiasis, including infections refractory to itraconazole and/or fluconazole. September's FDA approval was for the prophylaxis of invasive Aspergillus and Candida infections in patients 13 years and older who are at risk of developing fungal infections because they are immunocompromised.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
