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New and Generic Drug Approvals


August 30, 2012
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Alfuzosin Hydrochloridealfuzosin hydrochlorideTablet, Extended Release; OralAurobindo PharmaApproval
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release; OralWockhardt LtdApproval
LinzesslinaclotideCapsule; OralForest Labs IncApproval
NeoralcyclosporineCapsule; OralNovartisLabeling Revision
NeoralcyclosporineSolution; OralNovartisLabeling Revision
Revatiosildenafil citrateTablet; OralPfizerEfficacy Supplement with Clinical Data to Support
Revatiosildenafil citrateSolution; IntravenousPfizerEfficacy Supplement with Clinical Data to Support
RevatiosildenafilSuspension; OralPfizer IncApproval
SandimmunecyclosporineInjectable; InjectionNovartisLabeling Revision
SandimmunecyclosporineSolution; OralNovartisLabeling Revision
SandimmunecyclosporineCapsule; OralNovartisLabeling Revision
SubsysfentanylSpray; SublingualInsys TherapLabeling 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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