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Posts Tagged ‘FDA’

topamaxThe AP (10/15) reported, “Mylan Inc. said Thursday it received regulatory approval for its version of Johnson & Johnson’s epilepsy drug Topamax [topiramate], and began shipping” the “15 milligram and 25 milligram topiramate sprinkle capsules.” The patents “on Topamax expired in March,” and the AP notes that “Teva Pharmaceutical Industries Ltd. also markets a generic version of the drug.”

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The AP (3/17) reported that Cephalon announced Tuesday “that patients taking Nuvigil (armodafinil) along with mood stabilizers in an eight-week midstage study showed improvement in depression symptoms. The drug, which is already approved to treat narcolepsy, was also well-tolerated by patients.” In the study, side effects “included mania, hypomania, depression, and suicidal thoughts, but were comparable with patients taking placebo. Restlessness and anxiety were also side effects experienced by the Nuvigil group.” Now, Cephalon “plans on moving the drug along to late-stage trials, which are larger in scale, to further test the drug’s effectiveness in treating bipolar disorder.”

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The Washington Post (2/24, H2, Vedantam) reports that last week, the Food and Drug Administration (FDA) “approved ‘deep brain stimulation’ for the treatment of intractable obsessive-compulsive disorder, or OCD.” The technique “involves surgically implanting electrodes deep within the brain to trigger electrical activity,” and it’s “the first time” it “has been approved for use in a psychiatric condition. The implants have been previously used to treat Parkinson’s disease and other movement disorders.” According to the Post, “the FDA approval suggests officials believe that deep brain stimulation might help reduce anxiety. The device was approved for use when conventional treatments, such as medications and talk therapy, have not worked.” The decision was based “on a small study that found deep brain stimulation improved the condition of 26 patients with persistent obsessive-compulsive disorder by an average of 40 percent.” The particular “device approved by the FDA is called Reclaim and is manufactured by Medtronic Inc.”

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The Wall Street Journal (1/2, Favole, Dooren) reports that the Food and Drug Administration (FDA) “approved more new drugs in 2008 than in any of the prior three years, a consolation of sorts to an industry struggling with greater scrutiny, thousands of layoffs, and thinning drug pipelines.” Specifically, the agency “approved 24 first-of-a-kind drugs in 2008, compared with 18 in 2007, 22 in 2006, and 20 in 2005.” In addition, FDA officials “approved dozens of other applications for new formulations or new uses of existing drugs.” But “few of the drugs approved in 2008 are likely to be blockbusters.” And, while the “pharmaceutical industry welcomes the approvals, industry analysts say 2008 will be remembered more for delays in the approval process.” The “agency missed its deadlines on 32 out of 159 drug applications through Oct. 31,” however, that may change because “legislation passed last year gave the FDA more money to hire additional drug reviewers along with other kinds of employees.” Yet, the legislation “also imposed new requirements on the agency that are now being implemented and are temporarily contributing to the slowdown in drug-approval times.”

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Three additional dosages strengths of Shire’s Adult ADHD drug “Vyvanse” have been introduced in the U.S.

http://www.pharmaceutical-business-review.com/article_news.asp?guid=47DD5436-E104-43E3-88B9-C358294750B0

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