Zydus receives final approval from USFDA for Triazolam Tablets

Triazolam tablets are used on a short-term basis to treat insomnia (difficulty falling asleep or staying asleep)

Zydus Lifesciences Limited (formerly known as Cadila Healthcare 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 (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.

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.

Triazolam tablets had annual sales of US $11.7 million in the United States according to IQVIA data (IQVIA MAT September, 2022).