Zydus Lifesciences (previously Cadila Healthcare) said that its American subsidiary — Zydus Pharmaceuticals (USA) has secured final approval from the US Food and Drug Administration (FDA) for Cariprazine Capsules, USP 1.5 mg, 3 mg, 4.5 mg, and 6 mg.

In December 2021, Zydus Lifesciences was given tentative approval from the FDA for the drug product.

The Cariprazine Capsules product from the Indian pharma company is a generic of VRAYLAR (Cariprazine), which is an atypical antipsychotic approved for schizophrenia treatment as well as for the acute treatment of manic or mixed episodes resulting from bipolar I disorder.

Zydus Lifesciences said that its subsidiary was one of the first applicants for abbreviated new drug application (ANDA) to file a substantially complete ANDA with a paragraph IV certification for Cariprazine Capsules, 1.5 mg, 3 mg, 4.5 mg, and 6 mg. Due to this, the company is eligible for 180 days of shared generic drug exclusivity for Cariprazine Capsules, 1.5 mg, 3 mg, 4.5 mg, and 6 mg.

The schizophrenia drug will be manufactured at its formulation manufacturing plant in Ahmedabad, said Zydus Lifesciences.

According to IQVIA MAT July 2022, the annual sales of Cariprazine Capsules were $2.39bn in the US.

As of 30 June 2022, Zydus Lifesciences has 322 approvals and filed more than 428 ANDAs since the start of the filing process in FY 2003-04.

  Ahmedabad, Cadila Healthcare, Cariprazine Capsules, India, Schizophrenia, US FDA, US Food and Drug Administration, VRAYLAR, Zydus, Zydus Lifesciences, Zydus Pharmaceuticals, Zydus Pharmaceuticals (USA)