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New and Generic Drug Approvals


January 3, 2013
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Alevenaproxen sodiumTablet; OralBayerManufacturing Change or Addition
Ondansetron Hydrochloride Preservative Freeondansetron hydrochlorideInjectable; InjectionEmcure Pharms LtdApproval
Prozacfluoxetine hydrochlorideCapsule; OralEli Lilly and CoLabeling Revision
Prozac Weeklyfluoxetine hydrochlorideCapsule, Delayed Rel Pellets; OralLillyLabeling Revision
Sarafemfluoxetine hydrochlorideCapsule; OralEli Lilly and CoLabeling Revision
Symbyaxfluoxetine hydrochloride; olanzapineCapsule; OralLillyLabeling Revision

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Missing Data Lead FDA Panel to Vote Against Rivaroxaban for ACS May 23, 2012 (Updated May 24, 2012) (Silver Spring, Maryland) — The missing data issues plaguing the ATLAS ACS 2 TIMI 51 trial of the factor Xa inhibitor rivaroxaban (Xarelto, Bayer Healthcare/Janssen Pharmaceuticals) have prevented the drug from earning the endorsement of the FDA Cardiovascular and Renal Drugs Advisory Committee. At its May 23 meeting, the panel voted six to four (with one abstention) against recommending that the FDA approve rivaroxaban for reducing the risk of thrombotic cardiovascular events in patients with acute coronary syndrome or unstable angina in combination with aspirin, aspirin plus clopidogrel, or ticlopidine. Janssen's application is based on the results of the ATLAS ACS 2 phase 3 and the ATLAS ACS TIMI 46 phase 2 trial. 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May 23, 2012   (Updated May 24, 2012)  (Silver Spring, Maryland)  —  The missing data issues plaguing the  ATLAS ACS 2 TIMI 51   trial of the factor Xa inhibitor  rivaroxaban  (Xarelto, Bayer Healthcare/Janssen Pharmaceuticals) have prevented the drug from earning the endorsement of the  FDA  Cardiovascular and Renal Drugs Advisory Committee. At its May 23 meeting , the panel voted six to four (with one abstention) against recommending that the FDA approve rivaroxaban for reducing the risk of thrombotic cardiovascular events in patients with acute coronary syndrome or unstable angina in combination with aspirin, aspirin plus  clopidogrel , or  ticlopidine . Janssen's application is based on the results of the ATLAS ACS 2 phase 3 and the  ATLAS ACS TIMI 46   phase 2 trial. The placebo-controlled ATLAS ACS 2 showed rivaroxaban reduced the risk of both all-cause and cardiovascular mortality while increasing the ri...
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Antidepressants Linked to Higher Diabetes Risk in Kids

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