“The company’s abbreviated regulatory submission is only the second generic submission approved by the USFDA for this product,” said Zydus
“The company’s abbreviated regulatory submission is only the second generic submission approved by the USFDA for this product,” said Zydus
Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) to market its generic version of the cholesterol-lowering drug Colestipol Hydrochloride 1mg strength tablets.
“The Company’s Abbreviated New Drug Application (ANDA) is only the second generic application approved by the USFDA for this product,” said Zydus. “The approved product, which is a generic version of Colestid, will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad,” it said.
“Colestipol hydrochloride is a highly complex macromolecule drug substance with little or no systemic absorption. The tablets are indicated as add-on therapy to diet to lower elevated total serum and LDL-C in patients with primary hypercholesterolaemia (elevated LDL-C) who have not responded adequately to diet,” said Zydus Lifesciences (formerly known as Cadila Healthcare). . .
“The group now has 330 permits and has filed over 400 ANDAs since the filing process began in fiscal 2003-04,” it said.
