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Zydus gets USFDA node for insomnia drug

 

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Zydus gets USFDA node for insomnia drug

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Triazolam Tablets USP, 0.125 mg and 0.25 mg.

Triazolam tablets are used on a short-term basis to treat insomnia (difficulty falling asleep or staying asleep). It works by slowing activity in the brain to allow sleep. The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India.

Triazolam tablets had annual sales of USD 11.7 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).

The group now has 339 approvals and has so far filed over 431* ANDAs since the commencement of the filing process in FY 2003-04