Zydus Lifesciences Ltd. has received final approval from the United States Food and Drug Administration (USFDA) to market Colestipol Hydrochloride Tablets in the strength of 1mg (US RLD: Colestid), said the pharmaceutical company on Monday.
As per the statement issued by the company, Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet.
Colestipol Hydrochloride is a highly complex macromolecule drug substance with little or no systemic absorption, stated the company.
It further said that Zydus' abbreviated new drug application (ANDA) is only the second generic application approved by USFDA for this product.
The drug will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad, stated the company.
The group now has 330 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04, it added.
( With inputs from ANI )
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