Regulatory UpdatesSep 5, 2026•1 min read

FDA Approves Apotex Latanoprost Ophthalmic Solution (ANDA077697)

By the PharmaCountry team

The FDA approved Apotex's ANDA077697 for a generic latanoprost ophthalmic solution, with labeling supplements approved in 2012 and 2015.

The U.S. Food and Drug Administration has granted approval for application ANDA077697 submitted by Apotex Inc. The approval covers a generic ophthalmic solution of latanoprost (0.005%). The product is listed as discontinued in marketing status. The original submission received approval on March 22, 2011. Subsequent supplemental submissions for labeling were approved on November 28, 2012, and December 17, 2015.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#Latanoprost #ANDA #FDA #ophthalmic #generic #Apotex