FDA announces several approvals

November 4, 2008

FDA as the agency announced several approvals. Here’s the run-down:

  • The FDA has approved Pfizer and UCB’s Toviaz extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. UCB gets an undisclosed milestone payment as a result of the approval.
  • The agency has granted approval for Akorn’s ANDA for Adenosine Injection USP for supraventricular tachycardia in cardiac patients.
  • Cephalon announced that Treanda has been approved for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
  • Salix Pharmaceuticals won marketing approval for Apriso, a drug indicated for the maintenance of remission of ulcerative colitis (UC) in adults.

Source: FierceBiotech