Zydus Lifesciences on Thursday announced that its subsidiary Zydus Worldwide DMCC has received final approval from the United States Food and Drug Administration (USFDA) to market Brexpiprazole tablets, which is used to treat mental conditions in adults.

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The drugmaker was one of the first applicants to submit a substantially complete Abbreviated New Drug Application (ANDA) with a "paragraph IV certification" for these tablets and therefore it is eligible for 180 days of shared generic drug exclusivity.

The clearance has been received from the US drug regulator to market Brexpiprazole tablets in the strength of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, Zydus Lifesciences said in a filing to the stock exchanges.

Brexpiprazole is an atypical antipsychotic drug which is used along with antidepressants for the treatment of major mental conditions like depression and schizophrenia in patients aged 13 years and above.

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ in Gujarat.

According to IQVIA data, Brexpiprazole tablets had annual sales of $1,548 million in the United States for the 12-month period ending September 2022.

Earlier this week, Zydus Lifesciences also received USFDA approval for Febuxostat Tablets which are used to control or reduce the high uric acid levels in patients suffering from gout. The pharma major also received USFDA nod to launch Topiramate Extended-Release Capsules in the US market through its subsidiary Zydus Pharmaceuticals (USA) Inc. The medicine is used for the treatment of epilepsy.

Zydus Lifesciences, formerly known as Cadila Healthcare Ltd, has 340 approvals and has so far filed over 431 ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Life ended 0.8 percent lower at Rs 448.80.