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# GMP Inspection Causes FDA Denial of Valeant Eye Drug
- URL: https://www.fdaweb.com/gmp-inspection-causes-fda-denial-of-valeant-eye-drug/
- Published: 2017-08-07T12:00:00.000Z
- Updated: 2026-09-14T22:39:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139320

FDA has issued Valeant Pharmaceuticals a complete response letter on its NDA for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intraocular pressure-lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The letter cites a GMP inspection at subsidiary Bausch + Lomb’s manufacturing facility in Tampa, FL, according to Valeant. FDA did not identify any efficacy or safety concerns with the NDA or additional clinical trials needed for approval, it says.