Abstract
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 chronicles 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 for 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 11 million patients have been exposed to Sevoflurane.
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