Drugs

New and Generic Drug Approvals

 

May 21, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Bicalutamide bicalutamide Tablet;Oral Apotex Inc Approval
Cardene nicardipine hydrochloride Injectable;Injection Chiesi Usa Inc Manufacturing Change or Addition
Cardene In 0.83% Sodium Chloride In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Manufacturing Change or Addition
Cardene In 0.86% Sodium Chloride In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Manufacturing Change or Addition
Cardene In 4.8% Dextrose In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Manufacturing Change or Addition
Cardene In 5.0% Dextrose In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Manufacturing Change or Addition
Catapres clonidine hydrochloride Tablet;Oral Boehringer Ingelheim Manufacturing Change or Addition
Clobex clobetasol propionate Spray;Topical Galderma Labs Lp Manufacturing Change or Addition
Erivedge vismodegib Capsule;Oral Genentech Labeling Revision
Felodipine felodipine Tablet, Extended Release;Oral Orchid Hlthcare Approval
Intron A interferon alfa-2b Vial Schering Labeling Revision
Levetiracetam levetiracetam Tablet, Extended Release;Oral Prinston Inc Approval
Lopinavir and Ritonavir lopinavir;ritonavir Pellets;Oral Cipla Ltd Tentative Approval
Methotrexate Sodium methotrexate sodium Tablet;Oral Orion Corp Orion Approval
Omidria ketorolac tromethamine; phenylephrine hydrochloride Solution;Irrigation Omeros Manufacturing Change or Addition
Pegintron peginterferon alfa-2b Syringe Schering Labeling Revision
Pegintron peginterferon alfa-2b Vial Schering Labeling Revision
Prolia denosumab Injectable; Subcutaneous Amgen Labeling Revision
Qutenza capsaicin Patch;Topical Acorda Manufacturing Change or Addition
Rebetol ribavirin Capsule;Oral Merck Sharp Dohme Labeling Revision
Rebetol ribavirin Solution;Oral Schering Labeling Revision
Savella milnacipran hydrochloride Tablet;Oral Cypress Bioscience Manufacturing Change or Addition
Stiolto Respimat tiotropium bromide;olodaterol Spray;Inhalation Boehringer Ingelheim Approval
Sylatron peginterferon alfa-2b Vial Schering Labeling Revision
Xgeva denosumab Injectable; Subcutaneous Amgen Labeling Revision
Zymar gatifloxacin Solution/Drops;Ophthalmic Allergan Labeling Revision

 

May 20, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Desogestrel and Ethinyl Estradiol desogestrel; ethinyl estradiol Tablet;Oral-28 Famy Care Ltd Approval
Iclusig ponatinib hydrochloride Tablet;Oral Ariad Manufacturing Change or Addition
Zerbaxa ceftolozane sulfate; tazobactam sodium Powder;Iv (Infusion) Cubist Pharms Labeling Revision
Zytiga abiraterone acetate Tablet;Oral Janssen Biotech Labeling Revision

 

May 19, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Glipizide glipizide Tablet, Extended Release;Oral Mylan Pharms Inc Approval
Neuraceq florbetaben f-18 Solution;Intravenous Piramal Imaging Manufacturing Change or Addition
Prograf tacrolimus Capsule;Oral Astellas Labeling Revision
Prograf tacrolimus Injectable;Injection Astellas Labeling Revision
Soriatane acitretin Capsule;Oral Stiefel Labs Inc Labeling Revision
Tapentadol tapentadol Tablet;Oral Roxane Tentative Approval

 

May 18, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Advil ibuprofen Tablet;Oral Pfizer Manufacturing Change or Addition
Altoprev lovastatin Tablet, Extended Release;Oral Andrx Labs Llc Manufacturing Change or Addition
Auryxia ferric citrate Tablet;Oral Keryx Biopharms Manufacturing Change or Addition
Commit nicotine polacrilex Troche/Lozenge;Oral Glaxosmithkline Cons Labeling Revision
Fortamet metformin hydrochloride Tablet, Extended Release;Oral Andrx Labs Llc Manufacturing Change or Addition
Gattex Kit teduglutide recombinant Powder;Subcutaneous Nps Pharms Inc Manufacturing Change or Addition
Hemangeol propranolol hydrochloride Solution;Oral Pierre Fabre Derma Manufacturing Change or Addition
Iluvien fluocinolone acetonide Implant;Intravitreal Alimera Sciences Inc Manufacturing Change or Addition
Invega Trinza paliperidone palmitate Suspension, Extended-Release;Injectable Janssen Pharms Approval
Iprivask desirudin recombinant Injectable;Subcutaneous Marathon Pharms Llc Manufacturing Change or Addition
Lamictal lamotrigine Tablet;Oral Glaxosmithkline Llc Efficacy Supplement with Clinical Data to Support
Lamictal Cd lamotrigine Tablet, Chewable;Oral Glaxosmithkline Llc Efficacy Supplement with Clinical Data to Support
Lamictal Odt lamotrigine Tablet, Orally Disintegrating;Oral Glaxosmithkline Llc Efficacy Supplement with Clinical Data to Support
Linezolid linezolid Tablet;Oral Teva Pharms Usa Approval
Lotrel amlodipine besylate; benazepril hydrochloride Capsule;Oral Novartis Labeling Revision
Namenda Xr memantine hydrochloride Capsule, Extended Release;Oral Forest Labs Llc Manufacturing Change or Addition
Neuraceq florbetaben f-18 Solution;Intravenous Piramal Imaging Manufacturing Change or Addition
Risedronate Sodium risedronate sodium Tablet, Delayed Release;Oral Teva Pharms Usa Approval
Sandostatin Lar octreotide acetate Injectable;Injection Novartis Manufacturing Change or Addition
Tapentadol tapentadol Tablet;Oral Actavis Elizabeth Tentative Approval
Tapentadol tapentadol Tablet, Extended Release;Oral Actavis Elizabeth Tentative Approval

 

May 15, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Azithromycin azithromycin Tablet;Oral Lupin Ltd Approval
Azithromycin azithromycin Tablet;Oral Lupin Ltd Approval
Azithromycin azithromycin Tablet;Oral Lupin Ltd Approval
Azithromycin azithromycin For Suspension;Oral Lupin Ltd Approval
Ceftazidime In Dextrose Container ceftazidime Injectable;Injection B Braun Labeling Revision
Clonidine Hydrochloride clonidine hydrochloride Tablet, Extended Release;Oral Actavis Elizabeth Approval
Desvenlafaxine desvenlafaxine Tablet, Extended Release;Oral Alembic Pharms Ltd Labeling Revision
Xiaflex collagenase clostridium histolyticum Solution; Injection Auxilium Pharms Efficacy Supplement with Clinical Data to Support

 

Page Last Updated: 05/22/2015
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