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FDA panel gives thumbs down to Cephalon ADHD drug...ba href=/hyperactivity/a/b disorder drug, for approval. The panel cited safety concerns, primarily the possibility of serious skin rashes, as the reason for its vote. Earlier in the day the panel voted unanimously that Sparlon is an effective treatment for ADHD. The panel, however, said it needed more data to evaluate whether its use could cause a severe and sometimes fatal skin rash condition known as Steven Johnson's Syndrome. Sparlon contains the same active ingredient, modafinil, as the Frazer, Pa., biotechnology company's sleep-disorder drug Provigil. Provigil is a lower dose formulation. Cephalon (NASDAQ: CEPH) is seeking to market the drug to children and adolescents ages 6 through 17. The FDA will make the final determination on Cephalon's Sparlon application. The federal agency typically follows the recommendations of its advisory panels. The Securities and Exchange Commission suspending trading of Cephalon stock Thursday because of the advisory panel meeting. Send us your comments More Latest News ExtraAmerica's pay scales We analyze compensation for jobs in the private sector. • 10 top-paying jobs • Who gets paid the least • Best-paying blue-collar jobs Related Company stories Panel says Cephalon drug is effective but hasn't voted on recommendation [Philadelphia] Hurdles ahead for Cephalon [Philadelphia] Pharmaceutical firms mix and match to hone pipelines [Philadelphia] Today's Latest News Stories Penn announces new aid policy FDA panel gives thumbs do... Panel says Cephalon drug is effective but hasn't voted on ......ba href=/hyperactivity/a/b disorder. The panel has not yet voted on whether to recommend its approval to the FDA. The FDA typically follows the recommendations of its advisory panels. Sparlon contains the same active ingredient, modafinil, as the Frazer, Pa., biotechnology company's sleep- disorder drug Provigil. The Securities and Exchange Commission suspended trading of Cephalon (NASDAQ: CEPH) stock Thursday because of the advisory-panel meeting. Cephalon is seeking to market the drug to children and adolescents ages 6 through 17. FDA staff reviewers have expressed concerns about the safety profile of Sparlon and side effects, such as a serious skin rash, found in a small number of patients taking the drug in clinical trials. FDA reviewers have also expressed concerns there is an increased risk of suicidal thoughts or attempts with Sparlon compared with a placebo. However, there were no completed suicide attempts with Sparlon and the difference was not statistically significant compared with the placebo. Send us your comments More Latest News ExtraAmerica's pay scales We analyze compensation for jobs in the private sector. • 10 top-paying jobs • Who gets paid the least • Best-paying blue-collar jobs Related Industry stories State commission will try to fix nursing home industry in crisis [Albany] McKesson names general counsel [San Francisco] Medical organization names new president [Houston] Aetna receives upgrade from Fitch Ratings [Orlando] Lenexa will get job... Teacher's sexual encounters with boy provoke snickers, outrage...ba href=/hyperactivity/a/b disorder, making it difficult for her to restrain the strongest desire of all. Still, can it possibly be right for a grown woman to have sex with a child who is, according to his parents, deeply hurt by the experience? It's a statement that some men looking at pictures of Lafave doubt. So it must come down to the boy, to the individual's reaction and legality. What happened was illegal in Florida. I know men who grew up in Cuba during the 1950s and were taken to bordellos by fathers at 14 as a rite of passage. But I have never heard of a mother doing that for a daughter. So it must be a matter of gender. CONTINUED pg1 ... 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 36 | 37 | 38 | 39 | 40 | 41 | 42 | 43 | 44 | 45 | 46 | 47 | 48 | 49 | 50 | 51 | 52 | 53 | 54 | 55 | 56 | 57 | 58 | 59 | 60 | 61 | 62 | 63 | 64 | 65 | 66 | 67 | 68 | 69 | 70 | 71 | 72 | 73 | 74 | 75 | 76 | 77 | 78 | 79 | 80 | 81 | 82 | 83 | 84 | 85 | 86 | 87 | 88 | 89 | 90 | 91 | 92 | 93 | 94 | 95 | 96 | 97 | 98 | 99 | All news |