Lilly withdraws FDA application for Cymbalta for pain
Posted by Administrator (admin) on Dec 03 2008 at 12:16 PM
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CHICAGO (Reuters) – Eli Lilly and Co Friday said that the company pulled out an application to market its anti-depressant Cymbalta for controlling chronic pain. U.S. health regulators had raised questions about the drug’s effectiveness and dosing.

According to Lilly, the decision to withdraw the supplemental New Drug Application for Cymbalta was taken after U.S. Food and Drug Administration reviewers questioned the design of supporting Lilly studies and statistical methodology.

Eli Lilly and Company is a global pharmaceutical company who also makes schizophrenia drug Zyprexa, osteoporosis treatment Evista, and cancer drug Alimta.

“This was a difficult decision, but we believe the updated data package will give the FDA a broader basis for reviewing our application,” said John Hayes, vice president of Lilly Research Laboratories.

The company said it is planning to resubmit the application to the FDA after adding data from a recently completed study in chronic osteoarthritis pain of the knee.

Lilly said that the decision won’t affect the drug’s existing FDA-approved applications. The drug has been approved by the FDA for major depressive disorder, generalized anxiety disorder and management of diabetic peripheral neuropathic pain and fibromyalgia.

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