Zydus Cadila gets USFDA nod to market generic schizophrenia drug

PTI, Dec 10, 2021, 6:36 PM IST

New Delhi: Drug firm Zydus Cadila on Friday said it has received approval from the US health regulator to market generic drug Cariprazine capsules, which are used in the treatment of schizophrenia. The company’s subsidiary has received tentative approval from the US Food and Drug Administration (USFDA) for Cariprazine capsules in the strengths of 1.5 mg, 3 mg and 4.5 mg, and 6 mg, the drug firm said in a statement.

Cariprazine is an atypical antipsychotic medication used for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar disorder.

The drug production will be done at the group’s formulation manufacturing facility in the Special Economic Zone (SEZ), Ahmedabad.

The group now has 325 approvals and has so far filed over 400 ANDAs (Abbreviated New Drug Applications) since the commencement of the filing process in FY 2003-04, the drugmaker noted.