Zydus Cadila Approved by the US Food and Drug Administration to market a generic schizophrenia drug
New Delhi:
The pharmaceutical company Zydus Cadila said on Friday it has received approval from the US health regulator to market the generic drug Cariprazine in capsule form, which is used in the treatment of schizophrenia.
The company’s subsidiary has received tentative approval from the United States Food and Drug Administration (USFDA) for Cariprazine capsules in 1.5 mg, 3 mg and 4.5 mg strengths. and 6 mg, the pharmaceutical company said in a statement.
Cariprazine is an atypical antipsychotic used for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar disorder.
Production of the drug will be carried out at the group’s formulation facility in the Special Economic Zone (SEZ), Ahmedabad.
The group now has 325 approvals and has filed more than 400 ANDA (Abbreviated New Drug Application) to date since the start of the application process in fiscal year 2003-04, the drugmaker notes.
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