Last Updated on October 17, 2024 by The Health Master
Zydus Lifesciences’s US subsidiary Zydus Pharmaceuticals (USA) Inc has received final approval from the US Food and Drug Administration (USFDA) to market Cariprazine capsules, USP 1.5 mg, 3 mg, 4.5 mg, and 6 mg, a company statement said.
The statement said that Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Cariprazine capsules, 1.5 mg, 3 mg, 4.5 mg, and 6 mg, and, therefore, is eligible for 180 days of shared generic drug exclusivity for the product, 1.5 mg, 3 mg, 4.5 mg, and 6 mg.
Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and the acute treatment of manic or mixed episodes associated with bipolar disorder.
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, it further added.
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