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J&J pain combination Ultracet approved

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Combo tablet consisting of J&J's Ultram (tramadol) and acetaminophen clears FDA Aug. 15 for short-term (five days or less) management of acute pain. Labeling for the non-narcotic analgesic says the onset of pain relief after Ultracet was faster than with tramadol alone, occurring in less than an hour. Duration of pain relief was longer than with acetaminophen alone, and analgesic effect "was generally comparable to that of…ibuprofen," labeling adds. J&J submitted the NDA Aug. 21, 1999, for chronic as well as acute pain and received an "approvable" letter in June 2000
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