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McNeil's Zomax

Executive Summary

FDA will make a decision by Oct. 31 as to whether or not Zomax can return to the market, according to an agency memo of a Sept. 7 meeting between FDA and J&J. McNeil withdrew the drug in March 1983 following reports of anaphylactic reactions. The company has sought to bring Zomax back with indications limited to long-term use in patients with intractable pain

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