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New Delhi: Drug firm Glenmark Pharmaceuticals on March 23 said it has received approval from the US health regulator for its generic Diltiazem Hydrochloride extended release capsules used for treatment of high blood pressure.
The company has received final approval from the United States Food & Drug Administration (USFDA) for Diltiazem Hydrochloride extended‐release capsules USP, in the strengths of 60 mg, 90 mg, and 120 mg, Glenmark said in a statement.
The product is a generic version of Biovail Laboratories Inc’s Cardizem SR extended‐release capsules in the same strengths, it added.
The company has been granted a competitive generic therapy (CGT) designation for these capsules, therefore, with this approval, Glenmark is eligible for 180 days of CGT exclusivity upon commercial marketing, the statement said.
According to IQVIA sales data for the 12-month period ending January 2021, the Cardizem SR extended‐release capsules, 60 mg, 90 mg, and 120 mg market (including brand and all available therapeutic equivalents) achieved annual sales of approximately USD 56.7 million, it added.
The company’s current portfolio consists of 170 products authorised for distribution in the US marketplace and 42 abbreviated new drug applications (ANDA’s) pending approval with the USFDA, Glenmark said.