FDA requests additional data on arthritis and pain drug, lumiracoxib

 

Basel, 23 September 2003 - Novartis announced today, that the US Food and Drug Administration (FDA) has requested the submission of the final report of the ongoing TARGET study as well as additional clinical data for lumiracoxib* for the indications of osteoarthritis and acute pain before marketing approval in the US may be granted. Ongoing clinical studies may in part address the information requested by the FDA.