FDA update on brand drugs for November 5, 2008

[chantell.reagan]

Apriso (mesalamine extended–release capsules):
Approval: maintenance of remission of ulcerative colitis (UC) in adults; launch expected in 1Q09
∙ Link to press release:

o Salix press release

Toviaz (fesoterodine fumarate):
Approval: once-daily treatment of overactive bladder (OAB) symptoms; available 1st half of 2009
∙ Link to press release:

o Pfizer press release

∙ Link to prescribing information:

o Prescribing information

Requip XL (ropinirole extended-release tablets):
New dosage strength: 12mg tablet
∙ Link to FDA letter:

o FDA letter

∙ Link to prescribing information:

o Prescribing information

Treanda (bendamustine hydrochloride) for Injection:
Expanded indication: indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab containing regimen
∙ Link to prescribing information:

o Prescribing information

Sources:

U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA