Zydus Lifesciences gets FDA final approval for Olanzapine tablets

Zydus Lifesciences said that it has secured final approval for Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10mg, 15 mg, and 20 mg from the US Food and Drug Administration (FDA).

The approval gives the Indian pharma company to manufacture and market the generic version of Zyprexa Zydis Orally Disintegrating Tablets.

Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 15 mg, and 20 mg are indicated for the treatment of some mental/mood conditions like bipolar disorder and schizophrenia.

They could also be used in combination with other medications for the treatment of depression.

Zydus Lifesciences gets FDA final approval for Olanzapine tablets. Photo courtesy of Zydus Cadila.

Olanzapine tablets belong to the atypical antipsychotics class of drugs and function by helping in the restoration of the balance of some natural substances in the brain.

Zydus Lifesciences will manufacture the drug at its formulation manufacturing plant in Moraiya, Ahmedabad, India.

As per IQVIA MAT December 2022, the estimated annual sales of Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 15 mg, and 20 mg in the US are $28.3 million.