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Lilly withdraws Cymbalta application
01 Dec 2008
Regulatory Affairs
Eli Lilly has withdrawn a supplemental new drug application for Cymbalta in the US.
The application it made to the Food and Drug Administration (FDA) related to the extended use of the drug as a therapy for chronic pain and did not affect its status as a treatment in other indications.
Lilly will resubmit the application in the first half of 2009, this time including additional data from a clinical study which was recently completed.
According to the firm, the new trial results are from a study of patients with chronic osteoarthritis in the knee.
"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, a vice-president at Lilly Research Laboratories.
Lilly recently completed the acquisition of ImClone Systems, which has now become a wholly-owned subsidiary of the company.
John Lechleiter, Lilly's president and chief executive officer, pointed out that the move gives his firm's oncology pipeline a boost.
