Fesoterodine approved in the U.S.
UCB entitled to receive milestone payment and royalties from Pfizer
UCB announced that the U.S. food and Drug Administration (FDA) has approved the anti-muscarinic agent Toviaz® (fesoterodine fumarate) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
The NDA approval was granted to Pfizer Inc., New York, USA, which in April 2006 acquired the exclusive world-wide rights to Toviaz® from Schwarz Pharma, now a member of the UCB Group. UCB will be entitled to receive royalties on the combined sales of Toviaz® and Pfizer's current Detrol® (tolterodine) product line. Upon this approval, UCB will also receive a milestone payment from Pfizer. Details of the agreement are not disclosed.
TOVIAZ is structurally related to Pfizer's OAB medication Detrol® LA (tolterodine tartrate extended-release capsules). The 4 mg and 8 mg doses of TOVIAZ allow dosing flexibility to optimize treatment based on individual patient response and tolerability.
Toviaz® is approved in the EU and was launched by Pfizer mid-2008.
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