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# Complete Response Letter for AZ COPD Drug
- URL: https://www.fdaweb.com/complete-response-letter-for-az-copd-drug/
- Published: 2019-10-01T12:00:00.000Z
- Updated: 2026-09-15T01:53:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145138

FDA has issued a complete response letter to AstraZeneca for its NDA for PT010 (budesonide/glycopyrronium/formoterol fumerate), an inhaled triple-combination therapy for patients with chronic obstructive pulmonary disease. The company says the NDA included data from the KRONOS Phase 3 trial. It says AstraZeneca will now work closely with FDA on next steps, including submitting for review recent results from ETHOS, a second positive Phase 3 trial that was not completed at the time the NDA was submitted.