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)
You may also be interested in...
FDA First Cycle Approval Rate Is Silver Lining In Cloud Of Dismal NME Count
Three-quarters of the new molecular entities cleared by FDA in 2007 were approved on the first review cycle, a high for this decade and a positive note to counterbalance the record low number of NMEs approved.
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Health And Wellness Weekly Trademarks Review: 16 April
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.