Zydus Life gets USFDA final approval for schizophrenia drug

Zydus Lifesciences announced that it has received final approval from the United States Food and Drug Administration (USFDA) to market Olanzapine orally disintegrating tablets.

Olanzapine Orally Disintegrating tablet is a reference listed drug of Zyprexa Zydis orally disintegrating tablets.

Olanzapine orally disintegrating tablets are used to treat certain mental/mood conditions such as schizophrenia and bipolar disorder. The drug may also be used in combination with other medication to treat depression. These tablets belong to a class of drugs called as atypical antipsychotics and work by helping to restore the balance of certain natural substances in the brain.

The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, India.

According to IQVIA MAT December 2022, Olanzapine orally disintegrating tablets had annual sales of $28.3 million in the United States.

As of 31 December 2022, the group has 351 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company's consolidated net profit jumped 24.5% to Rs 622.90 crore on 17.9% rise in net sales to Rs 4,159.80 crore in Q3 FY23 over Q3 FY22.

The scrip rose 1.18% to end at Rs 474.50 on Friday, 10 March 2023.

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