Enablex(TM), Novartis' novel M3 antagonist for overactive bladder, on track for 2004 launch
Novartis receives approvable letter from FDA
Basel, 3 October 2003 - Novartis has received an approvable letter from the US Food and Drug Administration (FDA) for Enablex(TM) (darifenacin hydrobromide) for the treatment of overactive bladder. Acquired by Novartis in 2003, Enablex is an M3 selective receptor antagonist (M3 SRA), which works by selectively blocking an important receptor involved in the control of bladder muscle contraction. Novartis expects to launch the drug in 2004 after completing a limited amount of additional clinical work requested by FDA.
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