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
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
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
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
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
