The FDA's Drug Approval Agenda for Next Week

 |  Includes: DRRX, PFE, PTIE, SLXP
by: Zvi Bar
This is a very busy week for the FDA, with four decisions and meetings. Next week, the FDA has one meeting and is expected to make a decision on a separate drug. After next week, it is expected that the FDA will not make any additional decisions until around the middle of July.
Here is a breakdown of the FDA's agenda for next week:
1. Xifaxan
Developed by: Salix Pharmaceuticals (NASDAQ:SLXP)
For: Irritable bowel syndrome (IBS)
FDA meeting date: June 20
Note: Xiafaxan was approved for travelers' diarrhea and hepatic encephalopathy, but the FDA rejected it for IBS in March, requesting more data. Salix is expected to update the public on data results following this meeting.
2. Remoxy
Developed by: Durect (NASDAQ:DRRX), Pain Therapeutics (NASDAQ:PTIE) and Pfizer (NYSE:PFE)
For: Moderate to severe pain (abuse-resistant opiate)
Expected FDA decision date: June 23
Note: Pfizer is also involved in another abuse-resistant opiate, acurox, upon which the FDA is expected to to decide this week.
The approval of either 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.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.