“The Abbreviated New Drug Application of the company is only the second generic application approved by USFDA for this product,” Zydus said
“The Abbreviated New Drug Application of the company is only the second generic application approved by USFDA for this product,” Zydus said
Zydus Lifesciences has received final approval from the U. S. Food and Drug Administration (USFDA) to market its generic version of cholesterol lowering drug Colestipol Hydrochloride tablets, in the strength of 1mg.
“The Abbreviated New Drug Application (ANDA) of the company is only the second generic application approved by USFDA for this product,” Zydus said. “The approved product, which is a generic version of Colestid, will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad,” it said.
“Colestipol Hydrochloride is a highly complex macro molecule drug substance with little or no systemic absorption. The 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,” Zydus Lifesciences (formerly known as Cadila Healthcare) said.
“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 said.
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