Drug Topics - January 2009 - (Page 22)

Issues & Trends Drug Pipeline: What to watch in 2009 eep an eye on key therapeutic areas in 2009, as new drugs go through the FDA pipeline. Key areas are cardiovascular disorders, central nervous system (CNS) disorders, respiratory disease, and diabetes, reported Brian W. Kolling, PharmD, at the recent Academy of Managed Care Pharmacy meeting in Kansas City, Mo. According to Keith Bradbury, executive director of drug information at Medco Health Solutions Inc., the FDA has delayed approval of many new drug applications (NDAs) as the agency struggles with implementing new regulations established by the 2007 FDA Amendment Act. “We are at a historic time in terms of the number of products the FDA has delayed or allowed the user end-date to pass and extended the review period,” Bradbury said. For this reason, he said, as many as 62 NDAs could be submitted in 2009. Of these, perhaps 25 will [ultimately] be approved. “There are about 40 to 45 drugs sitting at the FDA today waiting for action,” Bradbury said. According to Bradbury, a home run might occur in K the cardiovascular field. Bradbury was referring to rivaroxaban (Xarelto; Bayer/J&J); if approved, it will be the ﬁrst new oral anticoagulant to reach the market in more than 40 years. “This is potentially a multibilliondollar drug. It looks very promising,” Bradbury said. Another cardiovascular agent is prasugrel (Efﬁent; Lilly). “The $64,000 question: ‘Is the FDA going to be able to tease out from the data whether the drug is in the net beneﬁcial and not harmful?’ If this happens, then [clopidogrel (Plavix; Sanoﬁ-Aventis/Bristol Meyers Squibb)] is going to have some competition,” Bradbury said. Network SEE INDEX PAGE 10 Cardiovascular Generic products will continue to make inroads into the cardiovascular market as the top-selling statin, angiotensin II receptor blocker (ARB), and antiplatelet drug all go off patent by 2012. There is also a full ﬁeld of factor Xa inhibitors, with more than nine new products in the pipeline, two of which are now in phase 3 trials. Statins will still dominate cholesterol management, but combination prod- Issues & Trends For more info on this topic, see www.drugtopics.com 22 DRUG TOPICS Januar y 2009 W W W.D R U GTO P I C S .C O M GETTY IMAGES / 3D4MEDICAL / PURESTOCK /STOCKBYTE / WIN INITIATIVE Amanda Brower, Senior Editor http://www.drugtopics.com

Table of Contents Feed for the Digital Edition of Drug Topics - January 2009

Drug Topics - January 2009 Contents Letters Up Front Up Front in Depth Community Practice Drug Pipeline: What to Watch in 2009 OTC Community-Aquired MRSA Infections New Products Viewpoint

Drug Topics - January 2009

Drug Topics - January 2009 - Drug Topics - January 2009 (Page Cover1) Drug Topics - January 2009 - Drug Topics - January 2009 (Page Cover2) Drug Topics - January 2009 - Drug Topics - January 2009 (Page 1) Drug Topics - January 2009 - Drug Topics - January 2009 (Page 2) Drug Topics - January 2009 - Drug Topics - January 2009 (Page 3) Drug Topics - January 2009 - Contents (Page 4) Drug Topics - January 2009 - Contents (Page 5) Drug Topics - January 2009 - Contents (Page 6) Drug Topics - January 2009 - Contents (Page 7) Drug Topics - January 2009 - Contents (Page 8) Drug Topics - January 2009 - Contents (Page 9) Drug Topics - January 2009 - Contents (Page 10) Drug Topics - January 2009 - Contents (Page H1) Drug Topics - January 2009 - Contents (Page H2) Drug Topics - January 2009 - Contents (Page H1) Drug Topics - January 2009 - Contents (Page H2) Drug Topics - January 2009 - Contents (Page H3) Drug Topics - January 2009 - Contents (Page H4) Drug Topics - January 2009 - Contents (Page H5) Drug Topics - January 2009 - Contents (Page H6) Drug Topics - January 2009 - Contents (Page H7) Drug Topics - January 2009 - Contents (Page H8) Drug Topics - January 2009 - Contents (Page 13) Drug Topics - January 2009 - Up Front (Page 14) Drug Topics - January 2009 - Up Front (Page 15) Drug Topics - January 2009 - Up Front (Page 16) Drug Topics - January 2009 - Up Front (Page 17) Drug Topics - January 2009 - Up Front in Depth (Page 18) Drug Topics - January 2009 - Up Front in Depth (Page 19) Drug Topics - January 2009 - Community Practice (Page 20) Drug Topics - January 2009 - Community Practice (Page 20a) Drug Topics - January 2009 - Community Practice (Page 20b) Drug Topics - January 2009 - Community Practice (Page 21) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 22) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 23) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 24) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 25) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 26) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 27) Drug Topics - January 2009 - OTC (Page 28) Drug Topics - January 2009 - OTC (Page 29) Drug Topics - January 2009 - OTC (Page 30) Drug Topics - January 2009 - OTC (Page 31) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 32) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 33) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 34) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 35) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 36) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 37) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 38) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 39) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 40) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 41) Drug Topics - January 2009 - New Products (Page 42) Drug Topics - January 2009 - New Products (Page 43) Drug Topics - January 2009 - New Products (Page 44) Drug Topics - January 2009 - New Products (Page 45) Drug Topics - January 2009 - New Products (Page 46) Drug Topics - January 2009 - New Products (Page 47) Drug Topics - January 2009 - Viewpoint (Page 48) Drug Topics - January 2009 - Viewpoint (Page Cover3) Drug Topics - January 2009 - Viewpoint (Page Cover4) http://digital.modernmedicine.com/nxtbooks/advanstar/dt_200912http://digital.modernmedicine.com/nxtbooks/advanstar/dt_200911http://digital.modernmedicine.com/nxtbooks/advanstar/dt_200910http://digital.modernmedicine.com/nxtbooks/advanstar/dt_200909http://digital.modernmedicine.com/nxtbooks/advanstar/dt_200908http://digital.modernmedicine.com/nxtbooks/advanstar/dt_200907http://digital.modernmedicine.com/nxtbooks/advanstar/dt_200906http://digital.modernmedicine.com/nxtbooks/advanstar/dt_200905http://www.nxtbook.com/nxtbooks/advanstar/dt_200904http://www.nxtbook.com/nxtbooks/advanstar/dt_200903http://www.nxtbook.com/nxtbooks/advanstar/dt_200902http://www.nxtbook.com/nxtbooks/advanstar/dt_200901_v2http://www.nxtbook.com/nxtbooks/advanstar/dt_200901http://www.nxtbook.com/nxtbooks/advanstar/dt122908http://www.nxtbook.com/nxtbooks/advanstar/dt122208http://www.nxtbook.com/nxtbooks/advanstar/dt121508http://www.nxtbook.com/nxtbooks/advanstar/dt111008_v2http://www.nxtbook.com/nxtbooks/advanstar/dt120808http://www.nxtbook.com/nxtbooks/advanstar/dt120108http://www.nxtbook.com/nxtbooks/advanstar/dt112408http://www.nxtbook.com/nxtbooks/advanstar/dt111708http://www.nxtbook.com/nxtbooks/advanstar/dt111008http://www.nxtbook.com/nxtbooks/advanstar/dt110308http://www.nxtbook.com/nxtbooks/advanstar/dt102708http://www.nxtbook.com/nxtbooks/advanstar/dt102008http://www.nxtbook.com/nxtbooks/advanstar/dt101308http://www.nxtbook.com/nxtbooks/advanstar/dt100608http://www.nxtbook.com/nxtbooks/advanstar/dt092908http://www.nxtbook.com/nxtbooks/advanstar/dt092208http://www.nxtbook.com/nxtbooks/advanstar/dt090808http://www.nxtbook.com/nxtbooks/advanstar/dt090108http://www.nxtbook.com/nxtbooks/advanstar/dt082508http://www.nxtbook.com/nxtbooks/advanstar/dt081808http://www.nxtbook.com/nxtbooks/advanstar/dt081108http://www.nxtbook.com/nxtbooks/advanstar/dt080408http://www.nxtbook.com/nxtbooks/advanstar/dt072808http://www.nxtbook.com/nxtbooks/advanstar/dt072108http://www.nxtbook.com/nxtbooks/advanstar/dt070708http://www.nxtbook.com/nxtbooks/advanstar/dt063008http://www.nxtbook.com/nxtbooks/advanstar/dt062308http://www.nxtbook.com/nxtbooks/advanstar/dt061608http://www.nxtbook.com/nxtbooks/advanstar/dt060908http://www.nxtbook.com/nxtbooks/advanstar/dt060208http://www.nxtbook.com/nxtbooks/advanstar/dt052608http://www.nxtbook.com/nxtbooks/advanstar/dt051908http://www.nxtbook.com/nxtbooks/advanstar/dt051208http://www.nxtbook.com/nxtbooks/advanstar/dt042808http://www.nxtbook.com/nxtbooks/advanstar/dt042108http://www.nxtbook.com/nxtbooks/advanstar/dt041408http://www.nxtbook.com/nxtbooks/advanstar/dt040708http://www.nxtbook.com/nxtbooks/advanstar/dt033108http://www.nxtbook.com/nxtbooks/advanstar/dt032408http://www.nxtbook.com/nxtbooks/advanstar/dt031708http://www.nxtbook.com/nxtbooks/advanstar/dt031008http://www.nxtbook.com/nxtbooks/advanstar/dt030308http://www.nxtbook.com/nxtbooks/advanstar/dt022508http://www.nxtbook.com/nxtbooks/advanstar/dt021808http://www.nxtbook.com/nxtbooks/advanstar/dt021108http://www.nxtbook.com/nxtbooks/advanstar/dt020408http://www.nxtbook.com/nxtbooks/advanstar/dt012808http://www.nxtbook.com/nxtbooks/advanstar/dt012108http://www.nxtbook.com/nxtbooks/advanstar/dt011408http://www.nxtbook.com/nxtbooks/advanstar/dt010708http://www.nxtbook.com/nxtbooks/advanstar/dt121707http://www.nxtbook.com/nxtbooks/advanstar/dt121007http://www.nxtbook.com/nxtbooks/advanstar/dt120307http://www.nxtbook.com/nxtbooks/advanstar/dt112607http://www.nxtbook.com/nxtbooks/advanstar/dt111907http://www.nxtbook.com/nxtbooks/advanstar/dt111207http://www.nxtbook.com/nxtbooks/advanstar/dt110507http://www.nxtbook.com/nxtbooks/advanstar/dt102907http://www.nxtbook.com/nxtbooks/advanstar/dt102207http://www.nxtbook.com/nxtbooks/advanstar/dt101507http://www.nxtbook.com/nxtbooks/advanstar/dt100807http://www.nxtbookMEDIA.com

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