Category Archives: Approvable Letters

FDA Approval Track Record Since Advent of Complete Response Letters

It has been four months since FDA's CDER began issuing Complete Response Letters in place of Approvable or non-approval letters.  Looking back to August to get an idea of where we are in terms of the approval of new molecular … Continue reading

Posted in Approvable Letters, FDA Policy | 1 Comment

Cardiome and Astellas Announce Receipt of FDA Approvable Letter for KYNAPID

Today is supposed to mark the day that the FDA quits submitting approvable letters and starts issuing "complete response letters" – but it looks like one flew off the shelf just in the nick of time – at least per … Continue reading

Posted in Approvable Letters | Comments Off

A Not Approvable Letter That Outlines What is Necessary for Approval

This morning, Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced receipt of a not approvable letter from the FDA for iloperidone, an investigational atypical antipsychotic that was reviewed for the treatment of schizophrenia.  It is noteworthy on a few fronts. First, it … Continue reading

Posted in Approvable Letters | 1 Comment

Approvable Letter Update

While it seems that the rate for approvable letters has slowed down over last year, it is nevertheless brisk and I’ve been a bit remiss on keeping up to date.  As noted recently, the FDA has acknowledged that it will … Continue reading

Posted in Approvable Letters | 2 Comments

Approvable Letter Issued to Eurand

Eurand Pharmaceuticals announced last week that the company had received an approvable letter from the FDA for its NDA for EUR-1008 (pancrealipase capsules) for the treatment of exocrine pancreatic insufficiency (EPI).  The company did not state the FDA’s reasoning for … Continue reading

Posted in Approvable Letters | Comments Off