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# FDA Sends Valeant a Complete Response Letter on Eye Drug NDA
- URL: https://www.fdaweb.com/fda-sends-valeant-a-complete-response-letter-on-eye-drug-nda/
- Published: 2016-07-22T12:00:00.000Z
- Updated: 2026-09-14T21:16:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136256

FDA has given Valeant Pharmaceuticals a complete response letter on its NDA for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The agency’s letter cited GMP deficiencies documented during a preapproval inspection at Bausch + Lomb’s manufacturing facility in Tampa, FL. Valeant acquired Bausch + Lomb in 2013\. Valeant says the letter did not identify any efficacy or safety concerns related to the NDA, nor did it request any additional clinical trials needed for approval. The company intends to meet with the agency as soon as possible to work on a resolution and address the concerns.