FDA Sends Warning Letters to Allergan and Bioniche

ROCKVILLE, Md., Sept. 16, 2009--The FDA has posted on its website warning letters it sent to Allergan, Inc. and Bioniche Pharma. For Allergan, the agency said in its letter that a consumer website  and a launch display timeline for eyelash drug Latisse are misleading  "because they omit and minimize risks associated with Latisse." Regarding Bioniche Pharma, the FDA reviewed two internet web pages for Sotradecol on the Bioniche website and the AngioDynamics website. The FDA said, "The web pages are false or misleading because they present efficacy claims for Sotradecol but fail to communicate any information about the risks associated with the product."

 

www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM182630.pdf

www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM182632.pdf

 

www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM182628.pdf

www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM182629.pdf

Posted: September 2009


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