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FDA announces several approvals

It's a busy Monday morning at the 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.

- see the Toviaz release
- here's Akorn's release
- check out the Treanda release
- see Salix's release

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