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Mylan Gets Expert Panel Go-Ahead For Pretomanid In India

 
• By Anju Ghangurde

Tuberculosis drug pretomanid gets endorsement, with Phase III trial waiver, from a key expert panel that advises India's drugs regulator, but roll out plan needs to be defined under the country’s national TB program, say health activists.

Tuberculosis
Pretomanid On Course For India Debut • Source: Shutterstock

An expert panel that advises the Indian drugs regulator has cleared Mylan NV’s proposal for pretomanid subject to certain restrictions, though the new treatment for drug-resistant tuberculosis (DR-TB) appears to have been endorsed with a Phase III trial waiver.

The subject expert committee’s (SEC) go-ahead is significant since in September last year it opined that “data was not sufficient enough” to grant a clinical trial waiver for the drug in India

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