By my accounting, the FDA has just issued its fourth approvable letter so far in 2008. Compare that to 2007 when by this date, the agency had issued a whopping 12 approvable letters. And, according to an article carried on Pharmalot, the number of approvals has risen over last year.
The latest approvable letter was issued by the FDA on Friday, this time going to Salix Pharmaceuticals for balsalazide tablet studied as a treatment of mild–to–moderate active ulcerative colitis in patients 18 years and older.
No indication was given by the company as to the reasoning for the FDA determination or the timing for resolving issues.
Quick refresher on approvable letters – they are proprietary to the company, meaning only the company can reveal the contents. They mean that the FDA is willing to consider approval, but wants to see something done first. That "something" can be as easy as a label or name change, or as complicated, expensive and time-consuming as new trials to further define safety or efficacy.
Following the announcement on Friday, the Salix shares dropped nearly 4.67%.