US approvals of supplemental drug indications have been rising steadily, Tufts finds
New or modified indication approvals for existing prescription drugs have steadily increased in the USA since the late 1990s, according to an analysis recently completed by the Tufts Center for the Study of Drug Development.
The number of new or modified indication approvals - consent by the Food and Drug Administration to market drugs for other than the original indication, based on additional clinical studies - increased 17% from 1998-03 to 2004-09, Tufts CSDD found.
Drug developers, facing patent expirations on many drugs over the next few years and stagnant growth in new approvals in the USA and worldwide, are looking for new revenue sources, and supplemental approvals for existing products may be one such source.
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