Full Prescribing Information Important Safety Information Medication Guide

History of XYREM®

What Is an Orphan Drug?

Orphan drugs are given special status by the government due to the rarity of the conditions they treat. Because these diseases are so rare, the market for them is small, making orphan drugs economically undesirable to produce. Government assistance, via tax breaks, subsidy for research, and exclusivity gives companies the incentive to produce these drugs.[1]
In 1983, the United States legislature enacted the Orphan Drug Act, with the aim of encouraging drug companies to provide a home for promising treatments for such disorders. The government offers incentives to encourage manufacturers to develop and market drugs that might not have been developed otherwise.[2]
These drugs go through the normal FDA approval process. Once an orphan drug is approved for marketing, a doctor may prescribe it to his or her patients. If the drug is still in the experimental stage, the manufacturer may make it available to individuals on a compassionate-use basis, or individuals may be able to enroll in a clinical trial.[1]

Timeline to FDA Approval

  • Do not take XYREM if you take other sleep medicines or sedatives (medicines that cause sleepiness), or if you have a rare condition called succinic semialdehyde dehydrogenase deficiency.
  • Do not drink alcohol; you could have serious side effects.
To reach the pharmacy by phone please call:

 1-866-997-3688

To report a side effect
please call:

 1-800-520-5568


References:

  1. ^ US Food and Drug Administration. The Orphan Drug Act (as amended). Available at: http://www.fda.gov/orphan/oda.htm. Accessed September 13, 2011.
  2. ^ Neuman A. GHB’s path to legitimacy: an administrative and legislative history of Xyrem. Harvard Law School Legal Electronic Document Archive. http://leda.law.harvard.edu/leda/data/629/Neuman.html. 2004. Accessed March 3, 2010
  3. ^ US Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21196ltr.pdf. Accessed August 29, 2011.
  4. ^ US Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021196s005ltr.pdf. Accessed August 29, 2011.
  5. ^ Data on File Jazz Pharmaceuticals, Inc.
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