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FDA approves Pfizer's Geodon Capsules for the adjunctive maintenance treatment of bipolar disorder 21 Nov 2009 06:57 GMT
... Pfizer today announced that the U.S. Food and Drug Administration (FDA) has approved Geodon (ziprasidone HCI) Capsules for maintenance treatment of bipolar I disorder as an adjunct ...
FDA Approves Aripiprazole to Treat Irritability Associated With Autistic Disorder 21 Nov 2009 06:54 GMT
... FDA Approves Aripiprazole to Treat Irritability Associated With ... -- November 20, 2009 -- The US Food and Drug Administration has approved aripiprazole (Abilify) for the treatment of irritability ...
U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Treatment of Irritability Associated with Autistic Disorder in Pediatric Patients (Ages 6 to 17 Years) 21 Nov 2009 00:11 GMT
... ) and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for (aripiprazole) for the treatment of irritability associated ...
U.S. Food and Drug Administration Approves ABILIFY® (aripiprazole) for the Treatment of Irritability Associated with 21 Nov 2009 00:54 GMT
... (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY ® : (aripiprazole) for the treatment ...
News and FDA Updates for Bristol-Myers (NYSE:BMY), Lannett (NYSE:LCI), Vertex (Nasdaq:VRTX) 21 Nov 2009 18:26 GMT
... News and FDA Updates for Bristol-Myers (NYSE:BMY), Lannett (NYSE:LCI), Vertex ... Otsuka Pharmaceutical Co., Ltd. announced the U.S. Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for ...

Pfizer Receives FDA Approval For Geodon (Ziprasidone HCI) Capsules 21 Nov 2009 11:33 GMT
... The approval is based on clinical data demonstrating that ... associated with high rates of disability.3 “The FDA approval of Geodon provides an additional treatment option for patients with ... serious mental health disorders.” Geodon is also FDA-approved for the treatment of acute manic and ...
FDA approves sNDA for pediatric autism drug ABILIFY 21 Nov 2009 05:37 GMT
... display an ability to regulate their behavior or to delay gratification in... The U.S. Food and Drug Administration (FDA) has approved a new indication for Symbyax (olanzapine an... Roughly 10 million years ago, a major ...
Dendreon Receives FDA Acknowledgement of Complete Response 21 Nov 2009 04:30 GMT
... (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended ... section of the BLA for PROVENGE. If approved by the FDA, PROVENGE would represent the ...
ICT Fails To Accelerate Drug Approvals 21 Nov 2009 08:34 GMT
... Drug approvals are taking just as long as they ... expenditure on new information technology at the Food and drug Administration. So says a statistical analysis ... the Since the middle of the 1990s, FDA review intervals have been an important topic ...
Par's Generic Ultram ER Approved by the FDA 21 Nov 2009 06:57 GMT
... Par’s Generic Ultram ER Approved by the FDA Par Pharmaceutical won FDA approval and 180 days of marketing exclusivity for a generic version of Ortho-McNeil's pain-management drug ...

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FDA Advisory Committee Finds Data Support The Claim That SPIRIVA(R) HandiHaler(R) Reduces COPD Exacerbations 21 Nov 2009 03:12 GMT
... The U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee voted 11 to ... European approval in 2002. SPIRIVA HandiHaler was approved in the U.S. in 2004. COPD is ...
UPDATE 2-US FDA reviewing Abbott diet drug risks 21 Nov 2009 00:30 GMT
... Early findings suggest higher heart risks - FDA * FDA making no conclusions, analysis ongoing ... a higher risk of cardiovascular problems, the Food and Drug Administration said on Friday. "The analysis of these ... a history of cardiovascular problems. "Sibutramine is approved for patients who are obese and have ...
Pfizer gets FDA approval for intravenous Revatio 21 Nov 2009 19:22 GMT
... Pfizer gets FDA approval for intravenous Revatio NEW YORK -- ... Drug developer Pfizer Inc. said Friday the Food and Drug Administration approved an intravenous version of its high blood ...
Lawyer Applauds FDA Crackdown On Use Of Pain Pumps After Shoulder Surgery 21 Nov 2009 09:13 GMT
... report confirms that pain pumps were never approved for use in joints. Robert K. Jenner ... In announcing the new warnings requirement, the FDA analyzed 35 reports of shoulder chondrolysis reported to the FDA from 2006 ...
News and FDA Updates for Covidien (NYSE:COV), Antigenics (NASDAQ:AGEN), Inovio (NYSE:INO) 21 Nov 2009 18:26 GMT
... News and FDA Updates for Covidien (NYSE:COV), Antigenics (NASDAQ:AGEN), Inovio ... database of Clinical Trials and upcoming FDA approvals & decisions. A complete list of all ... provider of healthcare products, announced the U.S. Food and Drug Administration (FDA) has set a new ...
News and FDA Updates for Genta (OTC:GETA), POZEN (NASDAQ:POZN), Novavax (Nasdaq:NVAX) 21 Nov 2009 18:26 GMT
... News and FDA Updates for Genta (OTC:GETA), POZEN (NASDAQ:POZN), Novavax (Nasdaq:NVAX) ... database of Clinical Trials and upcoming FDA approvals & decisions. A complete list of all ...
News and FDA Updates for BD (NYSE:BDX), Soligenix, Inc. (OTC:SNGX) 21 Nov 2009 18:26 GMT
... News and FDA Updates for BD (NYSE:BDX), Soligenix, Inc. (OTC:SNGX) BioMedReports.Com, ... database of Clinical Trials and upcoming FDA approvals & decisions. A complete list of all ...
News and FDA Updates for OPTIMIZERx (OTC:OPRX), Dendreon (Nasdaq:DNDN), Ligand (NASDAQ:LGND) 21 Nov 2009 18:26 GMT
... News and FDA Updates for OPTIMIZERx (OTC:OPRX), Dendreon (Nasdaq:DNDN), Ligand ... database of Clinical Trials and upcoming FDA approvals & decisions. A complete list of all ... 11/20/09, Dendreon Corporation (Nasdaq:DNDN) announced the U.S. Food and Drug Administration (FDA) provided written acknowledgement which ...
News and FDA Updates for GLG Life Tech (NASDA:GLGL), PharMerica (NYSE:PMC), Cyberonics (Nasdaq:CYBX) 21 Nov 2009 18:26 GMT
... News and FDA Updates for GLG Life Tech (NASDA:GLGL), PharMerica (NYSE:PMC), ... database of Clinical Trials and upcoming FDA approvals & decisions. A complete list of all ...
Pfizer's Geodon gets expanded FDA approval 21 Nov 2009 01:42 GMT
... NEW YORK -- Pfizer Inc. said Friday the Food and Drug Administration approved Geodon as a part of a combination maintenance treatment for bipolar disorder in adults. ...

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UPDATE: FDA Reviewing Safety Of Weight-Loss Drug Meridia 21 Nov 2009 02:14 GMT
... UPDATE: FDA Reviewing Safety Of Weight-Loss Drug Meridia (Updates ... FDA and Abbott) WASHINGTON -(Dow Jones)- The Food and Drug Administration Friday said it was conducting a safety ... profile of [Meridia] when used in the approved patient population," he said. The drug was ...
European medical advisory committee does not recommend approval of Avastin 21 Nov 2009 11:33 GMT
... disease following prior therapy from the US Food and Drug Administration (FDA) based on data from the BRAIN study ... across several types of cancer. It is approved in Europe for the treatment of the ...
Pfizer's Injectable Pulmonary Drug Revatio Wins Approval 21 Nov 2009 00:59 GMT
... Pfizer's Injectable Pulmonary Drug Revatio Wins Approval The FDA has approved Pfizer's injectable formulation of the pulmonary arterial hypertension (PAH) drug Revatio. This article is ...
Boston Scientific Announces FDA Clearance and CE Mark for WallFlex(R) Fully Covered Esophageal Stent 21 Nov 2009 04:30 GMT
... Corporation (NYSE: BSX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE Mark approval to market its WallFlexÂ® Fully Covered Esophageal Stent for the treatment of malignant esophageal ...
UPDATE 1-FDA OKs Abilify for child autism irritability 21 Nov 2009 01:20 GMT
... * Approved to treat aggression, self injury, tantrums * ... ANGELES, Nov 20 (Reuters) - The U.S. Food and Drug Administration has approved Bristol-Myers Squibb Co's ( ) ... disorder, the companies said on Friday. The FDA decision allows Abilify to be used in ...