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.
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