Zydus Lifesciences on Friday, December 30, 2022, announced that it received final approval from the United States Food and Drug Administration (USFDA) to market Triazolam tablets 0.125 mg and 0.25 mg.
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 patients to sleep.
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya near Ahmedabad in Gujarat.
According to IQVIA data, Triazolam tablets had annual sales of $11.7 million in the United States for the 12-month period ending September 2022.
Last month, Zydus Lifesciences' subsidiary Zydus Worldwide DMCC received the final approval from the USFDA for Selexipag tablets. Additionally, it also received 180 days of shared exclusivity for the same.
Selexipag is used for the treatment of pulmonary arterial hypertension (PAH), both to delay disease progression and reduce the risk of hospitalisation in adults.
Prior to that, the Ahmedabad-based generic drugs maker had received final clearance from USFDA to market Topiramate Extended-Release Capsules, which are used to prevent and control seizures in epilepsy patients.
Zydus Lifesciences, formerly known as Cadila Healthcare, has 339 approvals and has so far filed over 431 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in the financial year 204.
At its extraordinary general meeting (EGM) held on December 30, 2022, the members approved the appointment of Akhil Monappa and Upasana Kamineni Konidela as independent directors for the first term of five consecutive years effective from November 29, 2022.
Shares of Zydus Lifesciences ended 0.083 percent higher at Rs 420.30 on Monday.
