Pretomanid NDA for Drug-Resistant TB reviewed by FDA’s Antimicrobial Drugs Advisory Committee

Posted by Raymond Jablonski on Posted on

On June 6th, 2019, the Antimicrobial Drugs Advisory Committee convened to discuss the new drug application (NDA) # 212862 with the sponsor company: The Global Alliance for TB Drug Development, Inc. The NDA seeks approval of pretomanid (PA-824) in combination with the antibacterial drugs bedaquiline and linezolid for the treatment of drug-resistant or intolerant tuberculosis
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