Novel approvals surpass last year
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
With the Nov. 14 approval of Eisai's anti-epileptic drug Banzel (rufinamide), the Center for Drug Evaluation and Research's novel approval tally, of all new molecular entities and novel therapeutic biologics, reaches 18 (a number that gets higher including other CBER biologic approvals). That means that with more than a month left in the year, and numerous pending novel products (see user fee chart), FDA has already approved as many novel products as it did in 2007 (1Pharmaceutical Approvals Monthly January 2008, p. 3)