Zydus Cadila’s generic Cariprazine obtains tentative FDA approval
Patients with schizophrenia and manic or mixed episodes associated with bipolar disorder will soon have a generic medication to treat these conditions.
Zydus Cadila has obtained the Food and Drug Administration’s tentative nod for generic Cariprazine.
[Read more: Zydus Cadila gets tentative FDA OK for lenalidomide]
The tentative approval covers dosage strengths of 1.5 mg, 3 mg and 4.5 mg, and 6 mg.
Cariprazine is an atypical antipsychotic medication used for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar disorder.
[Read more: Zydus Cadila gets FDA permission for generic Xeljanz]
The drug production will be done at the group's formulation manufacturing facility in the Special Economic Zone in Ahmedabad.