Glenmark Pharmaceuticals Inc. – FDA CRL

The FDA issued a Complete Response Letter (CRL) for Glenmark Pharmaceuticals, Inc.'s New Drug Application (NDA 211746) for GSP 301 (olopatadine HCl and mometasone furoate) 665 mcg/25 mcg Nasal Spray, filed under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The non-approval stems from several key issues, including observations of objectionable conditions during a recent inspection of Glenmark Pharmaceuticals Ltd's manufacturing facility, which require satisfactory resolution. Product quality deficiencies were also noted, such as an inadequate supporting drug master file, missing 30-month stability results for registration batches (including leachables data), and insufficient validation data for the HDPE bottle extractables method with a description of acceptance criteria. While the proposed proprietary name, RYALTRIS, was acceptable, it must be resubmitted with the corrected application. Glenmark is required to provide a comprehensive safety update, integrating all new nonclinical and clinical data, detailing any changes in the safety profile, updated adverse event tabulations, and worldwide safety experience. To achieve approval, Glenmark must fully address all identified deficiencies and resubmit the application within one year. The drug product cannot be legally marketed until written approval is received.