Zydus Lifesciences bags USFDA nod for sleep disorder drug Triazolam

Ahmedabad: 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.

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.

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Zydus Lifesciences Limited, formerly Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the manufacture of generic drugs. Zydus group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil.

Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and the high-profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.

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