Zydus Cadila gets FDA tentative approval for Cariprazine Capsules
Zydus Cadila said that its subsidiary Zydus Pharmaceuticals (USA) has secured tentative approval from the US Food and Drug Administration (FDA) to commercialize Cariprazine Capsules in the strengths of 1.5 mg, 3 mg, and 4.5 mg, and 6 mg.
The reference listed rug (RLD) of Cariprazine Capsules is VRAYLAR.
Cariprazine, which is an atypical antipsychotic, is indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes resulting from bipolar disorder.
Zydus Cadila will manufacture Cariprazine Capsules at its formulation manufacturing facility in Ahmedabad.
The Indian pharma company said that it has 325 approvals to date and has so far filed more than 400 ANDAs since the start of the filing process in FY 2003-04.