FDA Update: Week Of August 23, 2010
By Lori Clapper, Web Editor
FDA Concerned About Fibromyalgia Drug
According to the Associated Press, the FDA has found that Jazz Pharmaceuticals' sodium oxybate (JZP-6) is effective in patients with the pain disorder fibromyalgia. However, regulators questioned whether the company has issued appropriate warnings against abuse, since it contains gamma hydroxybutyrate (GHB), an ingredient notoriously known as a "date rape" drug. FDA reviewers claim that this approval for fibromyalgia could widen the use of the drug, making it harder to control.
The Wall Street Journal reports Jazz Pharmaceuticals has been selling the product under the name Xyrem to treat narcolepsy, but is proposing to sell it under the name Rekinla for fibromyalgia.
Last Friday, an FDA advisory committee voted 20-2 against the approval of the drug. The FDA normally follows panel recommendations and a final decision should be announced by October 11.
Find out more in the Associated Press report.
Read the Wall Street Journal story.
Low Blood Pressure Drug Could Lose FDA Approval
Shire could lose FDA approval for its low blood pressure drug ProAmantine (midodrine hydrochloride). The FDA claims neither Shire nor any generic manufacturer has demonstrated the drug's clinical benefits, like improving a patient's ability to perform life activities. The medicine was originally approved in 1996 under the FDA's accelerated approval regulations for drugs that treat serious or life-threatening diseases. Generic versions of the drug are made by Apotex Corp., Impax Laboratories, Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories.
CDRH/FDA Offers Live Webinar
FDA Discussion on the Draft 510(k) and Use of Science in Regulatory Decision Making Reports
August 31 | 1:00 PM EDT
CDRH has published Preliminary Internal Evaluations, including comprehensive assessments on both the 510(k) premarket review process, and the use of science in CDRH's regulatory decision making.