7 Pharmaceuticals Awaiting FDA Decisions This Week

by: Zvi Bar

The FDA has a busy week this week. Some months go by with less FDA activity than will occur over the next few days. The FDA is expected to approve or reject three drugs and has a meeting scheduled on a fourth drug.

Below is a breakdown of the treatments upon which the FDA will make a decision this week, along with the companies that developed the treatments, their purpose and other information relevant to the application:


  • Developed by: GlaxoSmithKline (NYSE:GSK) & Valeant Pharmaceuticals (VRX)

  • For: Epileptic seizures

  • Expected FDA decision date: June 14, 2011

  • Note: FDA requested a response letter from GlaxoSmithKline and Valeant, which they provided on April 15, 2011.


  • Developed by: Bristol-Myers Squibb (NYSE:BMY)

  • For: Prevention of kidney transplant rejections

  • Expected FDA decision date: June 15, 2011

  • Note: Belatacept was rejected by the FDA in 2010


  • Developed by: Acura Pharmaceuticals (NASDAQ:ACUR) & Pfizer (NYSE:PFE)

  • For: Pain (abuse-resistant opiate)

  • Expected FDA decision date: June 17, 2011

VEGF Trap-Eye:

  • Developed by: Regeneron Pharmaceuticals (NASDAQ:REGN) & Bayer (OTCPK:BAYRY)

  • For: Age-related macular degeneration

  • FDA meeting date: June 17, 2011

  • Note: expected FDA approval/rejection decision date is August 20, 2011.

The approval of any of these is likely to be at least somewhat supportive to these pharmaceutical companies, and particularly to the smaller ones that do not already have large arsenals of revenue producing drugs, including those going off patent protection.

The U.S. Food and Drug Administration ("FDA") approved 21 new drugs in 2010. Notably, no single developer submitted two of the approved drugs. Additionally, the total number, 21, was below the level approved in both 2009 and 2008.

So far, 2011 has been a reasonably good year for new drug approvals, with some anticipating that between 30 and 40 new drugs may be approved before year’s end.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.