ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Colestipol Hydrochloride Tablets USP, 1 g.
ANI’s Colestipol Hydrochloride Tablets are the generic version of the Reference Listed Drug (RLD) Colestid®. The current annual U.S. market for Colestipol Hydrochloride Tablets is approximately $81.3 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.