FDA accepts NDA for Eisai’s Banzel
WOODCLIFF LAKE, N.J. Eisai’s new drug application for a drug designed as an adjunctive treatment of seizures associated with a rare form of epilepsy has been accepted by the Food and Drug Administration, the drug maker said Monday.
Eisai said its drug, Banzel, is designed to treat seizures associated with Lennox-Gastaut syndrome in children ages 4 years and older and adults. The NDA is for an oral suspension formulation, which was developed to provide a new option for children over four years and adults who have trouble swallowing tablets.
The NDA was submitted to FDA on April 30.
FDA advisory committee shoots down Vivus’ Qnexa
MOUNTAIN VIEW, Calif. The possibility of a new drug for treating obesity suffered a setback Thursday as a Food and Drug Administration advisory committee voted against recommending its approval.
The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 10 to 6 against recommending approval for Vivus’ drug Qnexa (phentermine and topiramate), citing safety concerns such as the possibility of psychiatric problems and birth defects.
“We appreciate the advisory committee’s recognition of obesity as a significant health crisis and the challenges associated with the treatment of this disease,” Vivus CEO Leland Wilson said. “We are disappointed with the advisory committee’s vote.”
The company said it would attempt to address the committee’s concerns. An advisory committee vote is a recommendation, and while the FDA will take it into account when deciding whether to approve a drug, it is not bound to follow it.
Post-it launches Shopping Genius widget
LONDON 3M has developed a bargain-shopping widget with the help of its Post-it brand.
Inspired by usage of the classic Post-it note as a shopping list, 3M has developed an evolution of the shopping list for the digital age called Post-it Shopping Genius. How it works: Post-it Shopping Genius sits on your computer desktop, keeping an eye on the price changes for you, locating the cheapest price, and letting you know when it changes. The customizable application enables you to choose from thousands of electricals, durables and other consumer goods, and track up to five at a time.
The application — which can be directly downloaded from http://bit.ly/Post-itGenius and is available on iGoogle, Mac OS X desktop and Windows 7 / Vista desktops — displays up-to-date prices on many thousands of products, which are searchable within the tool.
In related news, 3M announced that it is offering a monthly monetary prize of 1,000 GBP ($1,542) or the value of a user’s shopping list if less as an incentive to those who refer the Shopping Genius application to a friend.