April 24, 2019

6 Jun 2019 FDA AMDAC: Discussion of Pretomanid’s NDA for MDR-XDR TB

Dear All:  FDA today posted a Federal Register announcement of an Antimicrobial Drugs Advisory Committee (AMDAC) meeting on 6 June 2019. The AMDAC will discuss pretomanid (formerly, PA-824) tablets for oral administration, “proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive

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