Zolpimist, NovaDel Pharma’s zolpidem tartrate oral spray was approved by FDA yesterday (12/22/2008) for short-term treatment of insomnia. The RLD is the popular sleep aid Ambien. In their press release, NovaDel indicates that the oral spray “may work faster” and Zolpimist is “bioequivalent to Ambien tablets.” According to the press release, Zolpimist was approved based on [...]
Archive for December, 2008
505(b)(2) zolpidem tartrate oral spray approved
Published December 23rd, 2008 in News Commentary. 0 CommentsFenofibrate (TriCor) active metabolite approved
Published December 16th, 2008 in News Commentary. 1 CommentIn a previous posting we commented on the battle between Abbott and Teva over Abbott’s generic defense strategy. Yesterday (12/15/2008), FDA approved Abbott’s TriLipix - fenofibric acid. Fenofibric acid is the active metabolite of fenofibrate. The approval includes an indication to allow use in combination with a statin. In fact, it was announced that Abbott [...]
People are often surprised when I tell them that 505(b)(2) applications can contain a new molecular entity (NME). In fact, a 505(b)(2) covers any NDA application that relies on pivotal efficacy or safety information that the sponsor does not own the rights to. So what is an NME?
Under FD&C 505(c)(3)(D) and 505(j)(5)(D) “a new chemical [...]
505(b)(2) Combination Meets Phase 3 Goals
Published December 3rd, 2008 in 505(b)(2) Issues and News Commentary. 0 CommentsHorizon Therapeutics announced yesterday that its “fixed-dose combination product containing ibuprofen and famotidine, demonstrated a statistically significant reduction in the incidence of non-steroidal anti-inflammatory drug (NSAID)-induced upper gastrointestinal (gastric and/or duodenal) ulcers in patients with mild-to-moderate pain when compared to ibuprofen alone.” Note that the drug development program contained two Phase 3 trials, one examining gastric [...]
Brand-name drugs no better than generics
Published December 3rd, 2008 in News Commentary. 0 CommentsRead the headline again - ‘Brand-name drugs no better than generics’. This headline was on MSNBC/MSN web site and originated from a Reuters article reporting on a study conducted by Dr. Aaron Kesselheim of Brigham and Women’s Hospital and Harvard Medical School in Boston. The study concluded that there is no evidence that brand-name drugs given [...]
What is a ‘483?
Published December 23rd, 2008 in News Commentary, Outsourcing and Uncategorized. 0 CommentsYou may read in the news or a company press release that a manufacturing site has received a ‘483. This is usually considered bad news. Indeed, failure to remedy observations in a ‘483 can lead to withheld product approvals or even plant closure.
When the FDA makes a visit to inspect a facility (manufacturer, lab, supplier, [...]