Zydus bags USFDA nod for Olanzapine Orally Disintegrating Tablets to treat certain mental conditions

Ahmedabad: Zydus Lifesciences Limited has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 15 mg, and 20 mg (USRLD: Zyprexa Zydis Orally Disintegrating Tablets).

Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 15 mg, and 20 mg are used to treat certain mental/mood conditions (such as schizophrenia and bipolar disorder). Olanzapine tablets 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 products will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).

Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 15 mg, and 20 mg had annual sales of USD 28.3 mn in the United States (IQVIA MAT Dec. 2022).

Medical Dialogues team had earlier reported that the company's subsidiary Zydus Worldwide DMCC had received final approval from the USFDA to market Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (USRLD: REXULTI tablets).

Read also: Zydus Lifesciences arm bags USFDA approval for schizophrenia drug Brexpiprazole

Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), an Indian Pharmaceutical company is a fully integrated, global healthcare provider. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals.

The group now has 351 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.

Read also: Zydus Lifesciences secures USFDA okay for Lenalidomide Capsules to treat cancer