An Historical Perspective of the Successful Development of Sevoflurane
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0092-8615198 Copyright Q 1998 Drug Information Association Inc.
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AN HISTORICAL PERSPECTIVE OF THE SUCCESSFUL DEVELOPMENT OF SEVOFLURANE CLAIRCALLAN,MD, MBA, LETICIADELGADO-HERRERA, RPH, MS, DAVIDGUZEK,RPH, MS, KATHLEENBLAHUNKA, PHARMD,AND THE SEVOFLURANE VENTURETEAM? Abbott Laboratories, Hospital Products Division, Abbott Park, Illinois
The drug development process has become extremely competitive over the past decade as regulations and patient safety concerns require lengthy and costly investigations to evaluate new products. The cost of development of a pharmaceutical product must be less than the return on investment over the market lifetime. To ensure profitability in this competitive environment, new products must penetrate global markets rapidly. Prior to entry, regulatory review and approval of a market application is required in each country. This overview chmnicles the rapid and successful drug development and global market application filing of Sevoflurane. In March 1992, Abbott Laboratories’ Hospital Products Division began to organize a clinical submission plan f o r Sevoflurane, a new inhalational anesthetic. To date, Sevoflurane is approved in 46 countries, including the United States. It has been well accepted in all markets. Worldwide, over I1 million patients have been exposed to Sevoflurane. Key Words: Abbott Laboratories; Global pharmaceutical markets; Inhalational anesthetic; Pharmaceutical product development; Sevoflurane
HISTORICAL BACKGROUND SEVOFLURANE IS AN inhalational anesthetic agent indicated for the induction and Reprint address: Leticia Delgado-Herrera, RPh. MS, Abbott Laboratories. Dept. 97V. Building AP30, 200 Abbott Park Road, Abbott Park, IL 60064-3537. tThe Sevoflurane Venture Team recognizes these individuals: A. Adee, A. Bartley-Arquilla, D. Belongia, S. Bohannon, C. Frosch, S. Galvez, J. Jennings, M. Klemz, Z. Latif, P. Pichotta, G. Pratt, P. Prokocimer. J. Sayre, T. Stickler, P. Vandergrift, and B. Willms; the Hospital Products Division of Abbott Laboratories: C. Begley, D. Cunningham. D. Grabenkort, J. Garapolo, S. Huang, J. Joseph, J. Kringel, J. M y . L. Meyer, S. Murphy, K. Pope, G. Ramsay, and M. Szela; the Pharmaceutical Products Division of Abbott Laboratories: B. Bopp, S. Burke, P. Cusick, F. Fort. M. Friedman, W. Giardina, M. Karol, K. Keller, C. Lanni, J. Machinist, D. Moyse, R. Patterson, and B. Sonders; the Inter-
maintenance of general anesthesia. This highly fluorinated derivative of methyl isopropyl ether was discovered at Travenol Laboratories in Deerfield, Illinois (currently Baxter Laboratories, Deerfield, IL) as part of a comprehensive effort to synthesize inhalational anesthetic agents with improved safety and efficacy profiles compared with halothane. Synthesis of Sevoflurane was first national Division of Abbott Laboratories: R. Bachand, D. Chapman, N. Conway, C. Fulwell, P. Guzek, M. Hodkinson, R. Horder. W. Mann, L. Mershimer, U. Ortell, J. Y.Pavd, and C. Ward; Maruishi Pharmaceuticals: K. Habuchi, K. Inoue,
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