Pascal Soriot
Executive Director and Chief Executive Officer
AstraZeneca Pharmaceuticals LP
1800 Concord Pike
Wilmington , DE 19850
United StatesFEI 1000198729Issued Aug 4, 2023The Office of Prescription Drug Promotion (OPDP)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1000198729.
Violations1
Issue DateAug 4, 2023
Product TypeDrugs
StatusClosed
Closeout LetterMay 31, 2024
Letter Details
Firm
AstraZeneca Pharmaceuticals LP
Location
Pascal Soriot
Executive Director and Chief Executive Officer
AstraZeneca Pharmaceuticals LP
1800 Concord Pike
Wilmington , DE 19850
United States
FEI Number
1000198729
Country
United States
Issue Date
August 04, 2023
Issuing Office
The Office of Prescription Drug Promotion (OPDP)
Product Type
Drugs
Status
Closed
Closeout Letter
May 31, 2024
Summary
AstraZeneca's professional sales aid (US-68433) for BREZTRI AEROSPHERE contained false or misleading claims about the drug's efficacy, misbranding the product in violation of the Federal Food, Drug, and Cosmetic Act. The promotional communication created a misleading impression regarding the overall benefits patients could expect from Breztri treatment for chronic obstructive pulmonary disease maintenance therapy. The Office of Prescription Drug Promotion determined that the sales aid's violations raised public health concerns due to its misrepresentation of the drug's therapeutic benefits.
AstraZeneca Pharmaceuticals LP FDA Warning Letter, August 4, 2023
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