Update on US regulatory review of PT010 in COPD

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01 October 2019 07:00 BST

Update on US regulatory review of PT010 in COPD

AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate), an inhaled triple-combination therapy and potential new medicine for patients with chronic obstructive pulmonary disease (COPD).

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The NDA submitted to the FDA by AstraZeneca included data from the Phase III trial KRONOS. The Company will now work

Source: Update on US regulatory review of PT010 in COPD

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