Glenmark gets USFDA nod for generic antipsychotic drug

PTI New Delhi | Updated on March 24, 2021

Company granted competitive generic therapy (CGT) designation for these tablets, making it eligible for 180 days of CGT exclusivity upon commercial marketing

Drug firm Glenmark Pharmaceuticals on Wednesday said it has received final approval from the US health regulator for its generic phenothiazine antipsychotic Chlorpromazine Hydrochloride tablets.

The company has received approval from the United States Food and Drug Administration (USFDA) for Chlorpromazine Hydrochloride tablets USP, in the strengths of 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, Glenmark said in a regulatory filing.

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The product is a generic version of GlaxoSmithKline’s Thorazine tablets in the same strengths, it added.

The company has been granted a competitive generic therapy (CGT) designation for these tablets. Therefore, with this approval, it is eligible for 180 days of CGT exclusivity upon commercial marketing, Glenmark said.

According to IQVIA sales data for the 12-month period ending January 2021, Thorazine tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg market (including brand and all available therapeutic equivalents) achieved annual sales of approximately $108.6 million, it added.

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Thorazine is used to treat the symptoms of schizophrenia, psychotic disorders, nausea and vomiting, anxiety before surgery, intraoperative sedation, and intractable hiccups, among others.

Glenmark’s current portfolio consists of 171 products authorised for distribution in the US marketplace and 41 abbreviated new drug applications (ANDAs) pending approval with the USFDA, the filing said.

Shares of Glenmark Pharmaceuticals were trading at ₹464.30 per scrip on BSE, down 0.29 per cent from their previous close.

Published on March 24, 2021

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