Healthy Skepticism Library item: 18548

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

FDA Sends Novartis and AstraZeneca Letters for 'Misleading' Drug Info
Pharma Live 2010 Aug 5
http://pharmalive.com/news/index.cfm?articleID=721688

Abstract:

The FDA has posted letters on its website sent to Novartis and AstraZeneca. The agency states that a brochure for
Novartis’ hypertension drug Exforge, “is false or misleading because it overstates the efficacy of the drug, presents
unsubstantiated superiority claims and omits serious risks associated with the drug.” Regarding Novartis’ CML drug
Tasigna, the FDA said the “Facebook Share” social media widget, “is misleading because it makes representations about
the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug. For
AstraZeneca’s antipsychotic Seroquel XR, the FDA said the leave behind sheet for the drug is misleading.

Notes:

Exforge DDMAC Letter: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM221321.pdf

Exforge Promotional Material: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM221322.pdf

Tasigna DDMAC Letter: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM221325.pdf

Tasigna Promotional Material: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM221328.pdf

Seroquel XR DDMAC Letter: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM221315.pdf

Seroquel XR Promotional Material: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM221313.pdf