Zydus Lifesciences US arm bags USFDA nod for schizophrenia drug Cariprazine
Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder.
Ahmedabad: Zydus Lifesciences Limited's (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received final approval from the United States Food and Drug Administration (USFDA) to market Cariprazine Capsules, USP 1.5 mg, 3 mg, 4.5 mg, and 6 mg (USRLD: VRAYLAR).
Zydus was one of the first Abbreviated New Drug Application (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 Cariprazine Capsules, 1.5 mg, 3 mg, 4.5 mg, and 6 mg.
Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder.
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The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
Cariprazine Capsules had annual sales of USD 2.39 bn in the United States according to IQVIA MAT July 2022. The group now has 322 approvals and has so far filed over 428* ANDAs since the commencement of the filing process in FY 2003-04.
Zydus group is headquartered in Ahmedabad, India. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.
Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
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