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Drug firm Glenmark Pharmaceuticals on Wednesday said it has received final approval from the US health regulator because of 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.
The item is a generic version of GlaxoSmithKline’s Thorazine tablets in the exact strengths, it included.
The company has been granted a competitive generic therapy (CGT) designation for these tablets therefore, with this acceptance, it’s eligible for 180 days of CGT exclusivity upon commercial marketing, Glenmark stated.
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.
Thorazine is used to treat the symptoms of schizophrenia, psychotic disorders, nausea and vomiting, anxiety prior to surgery, intraoperative sedation, intractable hiccups amongst others.
Glenmark’s current portfolio consists of 171 products authorised for distribution in the US market and 41 abbreviated new drug applications (ANDAs) pending approval with the USFDA, the filing stated.
Shares of Glenmark Pharmaceuticals were trading at Rs 464.30 per scrip on BSE, down 0.29 percent from their previous close.
