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Thursday, 08/27/2015 7:35:53 AM

Thursday, August 27, 2015 7:35:53 AM

Post# of 3313
FDA Warning Letter:

"The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed the homepage of a website (webpage) for SURFAXIN® (lucinactant) Intratracheal Suspension (Surfaxin) submitted by Discovery Laboratories, Inc. (Discovery) under cover of Form FDA 2253. The webpage is false or misleading because it makes unsubstantiated superiority claims."

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM437488.pdf

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