FDA Fall Decision Calendar Features Some Likely Near-Term Movers

The accompanying table (click to enlarge) includes a calendar of expected FDA decision dates through the end of January 2009, including nine decisions due by the end of September.

Some likely near-term movers on the calendar include Cypress Bioscience (CYPB) + partner Forest Labs (FRX) with a pending decision on Milnacipran in the treatment of Fibromyalgia slated for the end of October in addition to results from a Phase 3 trial for the drug some time before year end.

Also, Discovery Labs (DSCO) is not listed on the calendar, but expects to file a complete response to a May 1st FDA approvable letter for Surfaxin by the end of September and expects a Class I review by the agency with a potential decision in just two months.

Another company not listed on the calendar is BioDelivery Sciences (BDSI), which expects approval for Onsolis [BEMA fentanyl] during the first half of 2009 after making modifications to the risk management program it previously submitted as required by the FDA for approval of the high-potency opioid pain medication.

Disclosure: None

Comments

[bristol queen:]

you forgot Remoxy, Kings oxycodone product decision in early December...

2008 Sep 27 10:43 PM

[Mike Havrilla:]

Check out this article with updated calendar and Remoxy decision date of 12/12/08 (previously I did not account for the priority review and had them listed later in 2009):
mikehav.blogspot.com/2...

2008 Sep 28 09:39 AM