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Pfizer Cardura

Executive Summary

"Bye-bye BPH symptoms" ad in the February issue of Urology cited by FDA in an April 2 letter for suggesting that "patients will no longer experience the symptoms of benign prostatic hyperplasia." In addition, FDA said the ad minimizes bolded warnings in Cardura labeling about syncope and hypotension. Pfizer also received a letter for a Trovan (trovafloxacin/alatrofloxacin) reminder ad in the February issue of Physician Assistant Journal. The journal ad contained a "pictorial representation of the lungs" and the claim "over one million prescriptions written." FDA said that "these expressed and implied claims are clear representations about the product, and thus would cause the ad to be considered a full product" ad, requiring brief summary. Both matters have been resolved with the agency, Pfizer said

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