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Zydus Life gets final nod from USFDA for generic version of insomnia drug

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator to market its generic version of Triazolam tablets used on a short-term basis to treat insomnia.

Cadila Healthcare changes name to Zydus Lifesciences Limited

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Press Trust of India New Delhi

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator to market its generic version of Triazolam tablets used on a short-term basis to treat insomnia.

The approval granted by the US Food and Drug Administration (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.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Dec 30 2022 | 5:08 PM IST

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