Zydus Lifesciences gets final approval from USFDA for Triazolam Tablets

30 Dec 2022 Evaluate

Zydus Lifesciences 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 (USRLD: HALCION tablets). 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 $11.7 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022). The group now has 339 approvals and has as of September 30, 2022 filed over 431 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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