PharmaGazette: Drug Regulations & Approval Archives

Drug Regulations & Approval Archives

Jul25	Topamax Gets 6 Month Pediatric Exclusivity Extension L. Lewis July 25, 2008 Know More: Drug Regulations & Approval The U.S. Food and Drug Administration has granted a six month pediatric exclusivity to Ortho-McNeil-Janssen Pharmaceuticals for its drug Topamax for use in patients aged 1 to 24 months with partial onset seizures.The extension does not give the drug FDA... Posted at 10:00 AM \| Permalink \| Comments
Jul14	FDA Changes Drug Application Process L. Lewis July 14, 2008 The U.S. Food and Drug Administration announced that it has revised its method of communicating that a drug cannot be approved as submitted to pharmaceutcial companies.Previously the FDA's Center for Drug Evaluation and Research (CDER) issued "approvable" or "non-approval" letters when... Continue Reading Posted at 10:00 AM \| Permalink \| Comments
Jun30	GSK Answers FDA on Cervarix L. Lewis June 30, 2008 GlaxoSmithKline (NYSE:GSK) announced that it has submitted its response to the U.S. Food and Drug Administration to questions the agency had in response to GSK's drug application for Cervarix.Cervarix, a vaccine for the prevention of cervical cancer, one of the largest drug... Continue Reading Posted at 12:00 PM \| Permalink \| Comments
Jun25	FDA Approves Combo Vaccine, Kinrix, for Kids L. Lewis June 25, 2008 The U.S. Food and Drug Administration has approved GlaxoSmithKline's combination booster vaccine, Kinrix.Kinrix protects children between 4 and 6 years old against diphtheria, pertussis, polio and tetanus and is approved for children who previously received GSK's Infanrix, which covers diptheria,... Continue Reading Posted at 12:00 PM \| Permalink \| Comments
	FDA Delays Prasugrel Approval 3 Months L. Lewis June 25, 2008 Eli Lilly & Co and Daiichi Sankyo announced the U.S. Food and Drug Administration had extended the period of review by three months for their anti-clotting drug, Prasugrel.Prasugrel received priority review status from the FDA in February based on studies that... Continue Reading Posted at 11:00 AM \| Permalink \| Comments
	Gardasil Gets FDA Non-Approval for Expanded Use L. Lewis June 25, 2008 Merck & Co. (NYSE:MRK) announced that the U.S. Food and Drug Administration did not approve the company's application to expand the use of Gardasil to include women between the ages of 27 and 45.Gardasil, a cervical cancer vaccine, was previously... Continue Reading Posted at 8:00 AM \| Permalink \| Comments
	FDA Approves Cymbalta for Fibromyalgia Avodart FDA Approved for Symptomatic Enlarged Prostate Humira, Remicade and Enbrel Under FDA Review for Cancer Link Outside Panel Reviews Promacta Wyeth Receieves Approvable Letter from FDA Promacta Fails to Control Bleeding According to FDA Wyeth Gets FDA Approvable Letter for Bazedoxifene Amitiza FDA Approved for IBS-C in Women Cimzia Approved by FDA to Treat Crohn's Disease Relistor FDA Approved for Opioid Induced Constipation Rotarix Gets FDA Approval Treanda Gets FDA Approval for Chronic Lymphocytic Leukemia FDA Warns on Unapproved and Misbranded Internet Drugs sanofi-aventis' Xyzal Tablets Get FDA Approval Teva Gets FDA Approval for Generic Fosamax Roche's Xeloda Gets EC Approval FDA Grants Priority Review for Multiple Myeloma Drug Velcade Asmanex Twisthaler from Schering Plough Gets FDA Approval Astella's Mycamine Gets Additional Indication FDA Approval FDA Approves New Version of Tekturna Abbott Gets FDA Approval for Humira for Plaque Psoriasis Welchol Receives FDA Approval For Type 2 Diabetes Birth Control Patch Gets Updated FDA Label Etravine Gets FDA Approval for HIV Tysabri Gets FDA Approval For Crohn's Eli Lilly and Co. Gets FDA Approval for Once-Daily Cialis Bystolic Gets FDA Approval for Treament of Hypertension Tentative FDA Approval for Generic Viread Forest Labs and Mylan's Bystolic Gets FDA Approval for Hypertension GlaxoSmithKline Receives FDA 'Complete Response' Letter for Cervarix Mylan Pharmaceuticals Inc.’s Lamotrigine Tablets Get Tentative FDA Approval FDA Decision Regarding Nexium and omeprazole: No Cardiac Risk Committe Votes to Approve Tetrabenazine for Chorea Diovan Gets FDA Approval for Treatment of Hypertension in Children Cymbalta Gets FDA Approval as Maintenance Treatment of Major Depressive Disorder FDA Drug Approval News INOmax by Ikaria Approved in Australia FDA Approves Abilify as Add-On for Major Depression Bayer and Onyx Nexavar FDA Approved for Liver Cancer FDA Approves AstraZeneca's Seroquel XR

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Jul25	Topamax Gets 6 Month Pediatric Exclusivity Extension L. Lewis July 25, 2008 Know More: Drug Regulations & Approval The U.S. Food and Drug Administration has granted a six month pediatric exclusivity to Ortho-McNeil-Janssen Pharmaceuticals for its drug Topamax for use in patients aged 1 to 24 months with partial onset seizures.The extension does not give the drug FDA... Posted at 10:00 AM \| Permalink \| Comments
Jul14	FDA Changes Drug Application Process L. Lewis July 14, 2008 The U.S. Food and Drug Administration announced that it has revised its method of communicating that a drug cannot be approved as submitted to pharmaceutcial companies.Previously the FDA's Center for Drug Evaluation and Research (CDER) issued "approvable" or "non-approval" letters when... Continue Reading Posted at 10:00 AM \| Permalink \| Comments
Jun30	GSK Answers FDA on Cervarix L. Lewis June 30, 2008 GlaxoSmithKline (NYSE:GSK) announced that it has submitted its response to the U.S. Food and Drug Administration to questions the agency had in response to GSK's drug application for Cervarix.Cervarix, a vaccine for the prevention of cervical cancer, one of the largest drug... Continue Reading Posted at 12:00 PM \| Permalink \| Comments
Jun25	FDA Approves Combo Vaccine, Kinrix, for Kids L. Lewis June 25, 2008 The U.S. Food and Drug Administration has approved GlaxoSmithKline's combination booster vaccine, Kinrix.Kinrix protects children between 4 and 6 years old against diphtheria, pertussis, polio and tetanus and is approved for children who previously received GSK's Infanrix, which covers diptheria,... Continue Reading Posted at 12:00 PM \| Permalink \| Comments
	FDA Delays Prasugrel Approval 3 Months L. Lewis June 25, 2008 Eli Lilly & Co and Daiichi Sankyo announced the U.S. Food and Drug Administration had extended the period of review by three months for their anti-clotting drug, Prasugrel.Prasugrel received priority review status from the FDA in February based on studies that... Continue Reading Posted at 11:00 AM \| Permalink \| Comments
	Gardasil Gets FDA Non-Approval for Expanded Use L. Lewis June 25, 2008 Merck & Co. (NYSE:MRK) announced that the U.S. Food and Drug Administration did not approve the company's application to expand the use of Gardasil to include women between the ages of 27 and 45.Gardasil, a cervical cancer vaccine, was previously... Continue Reading Posted at 8:00 AM \| Permalink \| Comments
	FDA Approves Cymbalta for Fibromyalgia Avodart FDA Approved for Symptomatic Enlarged Prostate Humira, Remicade and Enbrel Under FDA Review for Cancer Link Outside Panel Reviews Promacta Wyeth Receieves Approvable Letter from FDA Promacta Fails to Control Bleeding According to FDA Wyeth Gets FDA Approvable Letter for Bazedoxifene Amitiza FDA Approved for IBS-C in Women Cimzia Approved by FDA to Treat Crohn's Disease Relistor FDA Approved for Opioid Induced Constipation Rotarix Gets FDA Approval Treanda Gets FDA Approval for Chronic Lymphocytic Leukemia FDA Warns on Unapproved and Misbranded Internet Drugs sanofi-aventis' Xyzal Tablets Get FDA Approval Teva Gets FDA Approval for Generic Fosamax Roche's Xeloda Gets EC Approval FDA Grants Priority Review for Multiple Myeloma Drug Velcade Asmanex Twisthaler from Schering Plough Gets FDA Approval Astella's Mycamine Gets Additional Indication FDA Approval FDA Approves New Version of Tekturna Abbott Gets FDA Approval for Humira for Plaque Psoriasis Welchol Receives FDA Approval For Type 2 Diabetes Birth Control Patch Gets Updated FDA Label Etravine Gets FDA Approval for HIV Tysabri Gets FDA Approval For Crohn's Eli Lilly and Co. Gets FDA Approval for Once-Daily Cialis Bystolic Gets FDA Approval for Treament of Hypertension Tentative FDA Approval for Generic Viread Forest Labs and Mylan's Bystolic Gets FDA Approval for Hypertension GlaxoSmithKline Receives FDA 'Complete Response' Letter for Cervarix Mylan Pharmaceuticals Inc.’s Lamotrigine Tablets Get Tentative FDA Approval FDA Decision Regarding Nexium and omeprazole: No Cardiac Risk Committe Votes to Approve Tetrabenazine for Chorea Diovan Gets FDA Approval for Treatment of Hypertension in Children Cymbalta Gets FDA Approval as Maintenance Treatment of Major Depressive Disorder FDA Drug Approval News INOmax by Ikaria Approved in Australia FDA Approves Abilify as Add-On for Major Depression Bayer and Onyx Nexavar FDA Approved for Liver Cancer FDA Approves AstraZeneca's Seroquel XR

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