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Four months ahead of an expired patent on the acetylcholinesterase inhibitor donepezil's 5-mg and 10-mg dosages, the FDA approved a new 23-mg formulation for the treatment of moderate-to-severe Alzheimer disease (AD). This decision extended the patent with the newer product for 3 years beyond the November 2010 expiration and created competition for generic drug makers. While this may seem to be the routine machinations of the pharmaceutical industry, consumer watchdog groups heightened the profile of this decision. Now, a reanalysis of the FDA review data raises important questions regarding the consistency of standards for approval of FDA drug applications.
The randomized trial that led to approval of the 23-mg formulation included more tha…