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Eli Lilly resubmits supplemental approval application for Cymbalta


INDIANAPOLIS Drug maker Eli Lilly & Co. has resubmitted a supplemental approval application with the Food and Drug Administration for the use of a drug to treat chronic pain, after withdrawing it late last year.

The Indianapolis-based drug maker originally submitted the supplemental new drug application for Cymbalta (duloxetine hydrochloride) in the second quarter of last year, but withdrew it in November due to problems with the study design and statistical methodology.

The resubmission is based on a study in chronic pain due to osteoarthritis, the extension phase of a chronic low back pain study and previously completed studies in pain due to osteoarthritis and chronic low back pain, the company said.

“The additional chronic osteoarthritis pain and chronic low back pain data were not available at the time of the initial submission,” Lilly Research Laboratories VP John Hayes said. “We believe including these new data in the updated sNDA package will provide a broader clinical basis for the FDA to review the application.”

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