Zydus Lifesciences Gets USFDA Approval to Market Olanzapine Orally Disintegrating Tablets
Zydus Lifesciences, a leading global pharmaceutical company, has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Olanzapine Orally Disintegrating Tablets USP. The tablets are available in 5 mg, 10 mg, 15 mg, and 20 mg strengths and are used to treat mental/mood conditions such as schizophrenia and bipolar disorder. They may also be used in combination with other medications to treat depression.
The tablets belong to a class of drugs known as atypical antipsychotics and work by restoring the balance of natural substances in the brain. They will be manufactured at Zydus’ formulation manufacturing facility in Moraiya, Ahmedabad, India.
According to IQVIA MAT Dec. 2022 data, Olanzapine Orally Disintegrating Tablets USP had annual sales of USD 28.3 million in the United States. With this approval, Zydus now has 351 approvals and has filed over 440* abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.
Zydus’ latest approval reinforces its position as a global leader in the pharmaceutical industry, committed to improving the health and well-being of patients worldwide.
About Zydus Lifesciences:
An Indian multinational pharmaceutical company based in Ahmedabad, formerly known as Cadila Healthcare Limited, is now called Zydus Lifesciences Ltd. The company specializes in the production of generic drugs and was ranked 100th in the Fortune India 500 list for 2020.
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