Zydus Lifesciences bags USFDA final approval for Cariprazine Capsules; stock adds ~1%

12 Sep 2022 , 02:30 PM

The United States Food and Drug Administration (USFDA) has granted final approval to Zydus Lifesciences Limited’s (previously Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. to commercialise Cariprazine Capsules, USP 1.5 mg, 3 mg, 4.5 mg, and 6 mg.

Zydus was among the first ANDA applicants to file a substantially complete ANDA with a paragraph IV certification for Cariprazine Capsules, 1.5 mg, 3 mg, 4.5 mg, and 6 mg, making it 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 that is used to treat schizophrenia as well as acute manic or mixed episodes associated with Bipolar I disorder. The medicine would be manufactured at the group’s formulation manufacturing plant in Ahmedabad Special Economic Zone, India.

According to IQVIA MAT July 2022, Cariprazine Capsules had yearly sales of USD 2.39 billion in the United States.

Since the beginning of the filing procedure in FY 2003-04, the group has so far received 322 approvals and has submitted over 428 ANDAs.

At around 2.33 PM, Zydus Lifesciences was trading at Rs376.55 up by 0.59% from its previous closing of Rs374.35 on the BSE. The scrip touched intraday high and low of Rs381.40 and Rs373.10 respectively.

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