Zydus Lifesciences has received final approval from the US Food and Drug Administration (FDA) to market Colestipol Hydrochloride tablets in the strength of 1mg. 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, the company said in a statement.
Colestipol Hydrochloride is a highly complex macro molecule drug substance with little or no systemic absorption, it said.
It also said that Zydus’ ANDA is only the second generic application approved by FDA for this product. The drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad.