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Lioresal

Executive Summary

Medtronic's NDA for intrathecal Lioresal (Ciba-Geigy's baclofen) used with the company's Synchromed pump approved by FDA on June 17. However, Medtronic is still awaiting approval of the Synchromed device component for that indication, a spokesperson said. The company says it does not believe it can begin marketing the combination drug/device therapy until FDA responds to its supplemental premarket approval application for Synchromed. The baclofen solution for use in the pump was unanimously recommended for approval in June 1991 by FDA's Peripheral & Central Nervous System Drugs Advisory Committee for treating refractory spasticity caused by multiple sclerosis and spinal cord injuries ("The Pink Sheet" June 24, 1991, p. 9). Intrathecal baclofen has been "approvable" at FDA since Dec. 26.
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PS021107

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