FDA Premarket Approval: Process of Approving Ansaid as a Drug.

Upjohn is the beneficiary of a patent for Ansaid, a nonsteroidal, anti-inflammatory drug NsMD, marketed by The Upjohn Company since January 1989. It is primarily sold for the treatment of arthritis symptoms. The patent for Ansaid was originally granted to a United Kingdom drug manufacturer, the Boots Company, in February 1974. The patent expired in February 1991. However, its expiration date was extended until February 1993 under provisions of the Drug Price Competition and Patent Term Restoration Act of 1984.2 Although Upjohn applied to the Food and Drug Administration FDA in March 1982 for approval to sell Ansaid, premarket approval was not granted until October 1988. Upjohn believes that the 79-month approval period was excessive, saying the average approval time for other NSAIDs was 26 months. The following sections discuss our findings chronologically from the date of the Ansaid patent in 1974 to FDA premarket approval in 1988. We studied time periods to determine who, if anyone, was responsible for the events that collectively lengthened the Ansaid NDA approval process. Table 1 highlights various activities related to Ansaid approval that are discussed in the following sections of this report.