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December 26, 2017

Encouraging New Uses for Old Drugs

Author Affiliations
  • 1Washington University in St Louis School of Law, St Louis, Missouri
  • 2Leonard D. Schaeffer Health Policy Studies, Brookings Institution, Washington, DC
  • 3Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles
  • 4Public Policy, Pharmacy, and Economics, University of Southern California, Los Angeles
JAMA. 2017;318(24):2421-2422. doi:10.1001/jama.2017.17535

US Food and Drug Administration (FDA) approval of a new drug typically coincides with a period of patent protection, during which the manufacturer will often apply for additional indications to expand the market for the product. For example, the tyrosine kinase inhibitor imatinib (Gleevec; Novartis) was originally approved to treat Philadelphia chromosome–positive chronic myelogenous leukemia, but has since been approved for treatment of other cancers. Many noncancer drugs also follow this pattern, including botulinum toxin A (Botox; Allergan), which was originally approved for the treatment of strabismus and blepharospasm and subsequently approved for treatment of cervical dystonia, cosmetic uses, and chronic migraine.

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