fesoterodine receives us fda approval

Inpharma 1663 - 8 Nov 2008 Fesoterodine receives US FDA approval UCB has announced that the US FDA has approved its anti-muscarinic agent fesoterodine [Toviaz] extended- release tablets for the treatment of overactive bladder with symptoms of urge incontinence, urinary frequency and urgency. The new drug application was granted to Pfizer, New York, which acquired the exclusive worldwide rights to Toviaz from Schwarz Pharma, now a member of the UCB Group. UCB is entitled to receive royalties on the combined sales of Toviaz and Pfizer’s current tolderodine [Detrol] line. Following this approval, UCB will also receive a milestone payment from Pfizer, although details of this agreement are undisclosed. Toviaz is related structurally to Pfizer’s Detrol for overactive bladder. The 4mg and 8mg doses of Toviaz allow for dosing flexibility to optimise treatment based on patient tolerability and response. Toviaz is approved in the EU and was launched by Pfizer in mid-2008. UCB. Fesoterodine approved in the U.S. Media Release : 31 Oct 2008. Available from: URL: http://www.ucb-group.com 809094772 1 Inpharma 8 Nov 2008 No. 1663 1173-8324/10/1663-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Inpharma 1663 - 8 Nov 2008

Fesoterodine receives US FDAapproval

UCB has announced that the US FDA has approved itsanti-muscarinic agent fesoterodine [Toviaz] extended-release tablets for the treatment of overactive bladderwith symptoms of urge incontinence, urinary frequencyand urgency.

The new drug application was granted to Pfizer, NewYork, which acquired the exclusive worldwide rights toToviaz from Schwarz Pharma, now a member of theUCB Group. UCB is entitled to receive royalties on thecombined sales of Toviaz and Pfizer’s currenttolderodine [Detrol] line. Following this approval, UCBwill also receive a milestone payment from Pfizer,although details of this agreement are undisclosed.

Toviaz is related structurally to Pfizer’s Detrol foroveractive bladder. The 4mg and 8mg doses of Toviazallow for dosing flexibility to optimise treatment basedon patient tolerability and response. Toviaz is approvedin the EU and was launched by Pfizer in mid-2008.UCB. Fesoterodine approved in the U.S. Media Release : 31 Oct 2008. Availablefrom: URL: http://www.ucb-group.com 809094772

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