Category Archives: Approvable Letters

Approvable Letter Update

Posted on May 20, 2008 by Mark Senak

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 … Continue reading →

Posted in Approvable Letters | 3 Comments

FDA Issues Another Approvable Letter

Posted on May 7, 2008 by Mark Senak

This time, the letter was directed to Astellas, and it isn’t the first one. According to an Astellas press release that was issued today, the company stated that it received an approvable letter for its NDA for FK 506 Modified … Continue reading →

Posted in Approvable Letters | Comments Off on FDA Issues Another Approvable Letter

Approvable Letter for MRSA Treatment

Posted on March 18, 2008 by Mark Senak

Basilea Pharmaceutica announced today that the FDA has issued an approvable letter for its first-in-class anti-MRSA agent cephalosporin for which company sought an indication to treat skin infections and diabetic foot infections. According to the company, prior to approval the … Continue reading →

Posted in Approvable Letters | Comments Off on Approvable Letter for MRSA Treatment

Approvable Letter – Listing for 2007

Posted on February 20, 2008 by Mark Senak

I finally did it!  I have updated the listing of Approvable Letters that is housed in the left column of the blog under Resources by Me.  I now have all of the approvable letters listed that I have seen occur.  … Continue reading →

Posted in Approvable Letters, FDA Policy | 1 Comment

Impact of Approvable Letters 2007 – Part 2

Posted on January 9, 2008 by Mark Senak

Yesterday I posted about the impact of approvable letters and began by saying I have not yet been able to compare this year to other years, but my gut told me that it was a higher rate of approvables than … Continue reading →

Posted in Approvable Letters | 2 Comments