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DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE ECR Pharmaceuticals, a wholly owned subsidiary of Valeant Pharmaceuticals International Attention: J.. Michael Pearson, CEO Valeant Pharmaceuticals International 400 Somerset Corporate Center Bridgewater, NJ 08807 RE: ANDA 077273 TussiCaps® (hydrocodone polistirex and chlorpheniramine polistirex) Extended-release Capsules CII 1 MA 86 WARNING LETTER Dear Mr. Pearson: The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a professional sales aid (DTUS3B) (sales aid) for TussiCaps® (hydrocodone polistirex and chlorpheniramine polistirex) Extended-release Capsules CII (TussiCaps) submitted by ECR Pharmaceuticals under cover of Form FDA 2253.. In order to clearly identify the violative promotional piece(s) and/or activity and focus on the corrective message(s), OPDP recommends that corrective piece(s) include a description of the violative promotional pieces and/or activity, include a summary of the violative message(s), provide information to correct each of the violative message(s), and be free of promotional claims and presentations..
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