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Wyeth-Ayerst/Astra’s Dalgan

Executive Summary

Synthetic agonist/antagonist opioid analgesic, approved Dec. 29 and licensed by Wyeht-Ayerst to Astra, will be not be a scheduled drug. Earlier this year, FDA's Drug Abuse Advisory Committee recommended that dezocine be placed in Schedule V of the Controlled Substances Act based on the drug's abuse potential ("The Pink Sheet" Aug. 14, p. 4). Of the four other agonist/antagonist analgesics to reach the U.S., two have been scheduled: Sterling's Talwin and Norwich-Eaton's Buprenex. Dalgan's approval letter states that the company has agreed to "perform a postmarketing surveillance study to assess the incidence of abuse during the first three years of marketing.

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