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Pretomanid Approval For Resistant TB: With Regulatory Flexibility Comes Usage Restrictions

 
• By Michael Cipriano

US FDA's approval of the TB Alliance's pretomanid regimen for highly treatment-resistant tuberculosis comes with an LPAD designation and advisory committee-requested language to limit use.

Tuberculosis

The US Food and Drug Administration showed off its willingness to allow for regulatory flexibility in in certain clinical development programs with its approval of the Global Alliance for TB Drug Development's pretomanid regimen, but the agency also inserted restrictions in the labeling to help ensure its use remains limited.

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