Xiidra(Lifitegrast) Instructions:Uses,Dosage, Side Effects

Lifitegrast Ophthalmic Solution, 5% is a topical ophthalmic medication that has been determined by the U.S. Food and Drug Administration (FDA) to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xiidra Ophthalmic Solution, 5%, developed by Novartis Pharmaceuticals Corporation. This generic formulation is produced by Ingenus Pharmaceuticals, LLC, with RiconPharma LLC serving as the U.S. agent. The drug is subject to regulatory review under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and its approval is contingent upon the expiration of certain patents.

The document outlines the regulatory status of the drug, including its tentative approval due to ongoing patent protections associated with the reference product. Lifitegrast Ophthalmic Solution, 5% may not be marketed until final FDA approval is granted, which is expected after the expiration of the last relevant patent. The document also details requirements for facility compliance, annual fees, and the process for requesting final approval, but does not provide clinical usage details, mechanism of action, or specific therapeutic indications.