Allergan, Inc. (AGN), GlaxoSmithKline plc (ADR) (GSK), and Three ‘Cannot Miss’ FDA Actions This Week

Is this the End-o for Aveed?
Finally, on Thursday we have an FDA panel meeting for Endo Health Solutions Inc (NASDAQ:ENDP)‘ Aveed, with is an extended-release male hypogonadism treatment.

The drug itself was acquired when Endo purchased Indevus Pharmaceuticals in early 2009 and is on its second go-around after receiving a complete response letter in its first attempt to gain approval. That CRL spelled out the FDA’s concerns regarding very rare, but serious, adverse side effects, which included post-injection anaphylaxis and pulmonary oil microembolism. The FDA also noted that Endo’s risk evaluation and mitigation strategy was insufficient.

It’s been more than three years since that initial CRL, so this should definitely be an interesting FDA panel meeting to say the least. Safety remains the primary concern, which the FDA panel may touch on and will more than likely determine how likely Aveed is to be approved once it goes before the FDA itself.

The article 3 Can’t-Miss FDA Actions This Week originally appeared on

Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.

Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.