By Carlo Martuscelli

 

AstraZeneca PLC (AZN.LN) said Tuesday that the U.S. Food and Drug Administration hadn't approved its new drug application for PT010, an inhaled treatment for chronic obstructive pulmonary disease.

The British pharmaceutical company said that the regulator issued a letter provisionally denying its request to approve the drug.

Astra said it will now work with the FDA to move the process forward by providing previously unsubmitted data which wasn't available when the first application was made.

PT010 was approved in Japan in June under the name Breztri Aerosphere, and is under regulatory review in China and the European Union.

 

Write to Carlo Martuscelli at carlo.martuscelli@dowjones.com

 

(END) Dow Jones Newswires

October 01, 2019 03:46 ET (07:46 GMT)

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