USFDA gives final approval for this Insomnia drug

The approval granted by the USFDA is to market Triazolam tablets of strengths 0.125 mg and 0.25 mg, the company said in a regulatory filing.

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USFDA Approval
USFDA Approval

Last Updated on October 15, 2024 by The Health Master

Zydus Lifesciences Ltd. announced that it has received final approval from the US Food and Drug Administration (USFDA) to market its generic version of Triazolam tablets, which are used to treat insomnia in the short term.

The approval granted by the USFDA is to market Triazolam tablets of strengths 0.125 mg and 0.25 mg, the company said in a regulatory filing.

The medicine is 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.

It will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, the company said.

Triazolam tablets had annual sales of USD 11.7 million in the US, the company said, citing IQVIA MAT September 2022 data.

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