Mar 032016
 

March 3, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Almotriptan Malate almotriptan malate Tablet;Oral Ajanta Pharma Ltd Approval
Cerebyx fosphenytoin sodium Injectable;Injection Parke Davis Labeling Revision
Cerezyme imiglucerase Injectable;Injection Genzyme Manufacturing Change or Addition
Epi E Z Pen Jr epinephrine Injectable;Intramuscular Mylan Speclt Manufacturing Change or Addition
Epipen epinephrine Injectable;Intramuscular, Subcutaneous Mylan Speclt Manufacturing Change or Addition
Epipen E Z Pen epinephrine Injectable;Intramuscular Mylan Speclt Manufacturing Change or Addition
Epipen Jr. epinephrine Injectable;Intramuscular, Subcutaneous Mylan Speclt Manufacturing Change or Addition
Oxytrol For Women oxybutynin Film, Extended Release;Transdermal Allergan Sales Llc Labeling Revision
Proventil-Hfa albuterol sulfate Aerosol, Metered;Inhalation 3m Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Zarxio filgrastim-sndz Injectable;Injection Sandoz Inc Labeling Revision
Mar 022016
 

March 2, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Atnaa atropine; pralidoxime chloride Injectable;Intramuscular Us Army Manufacturing Change or Addition
Duodote atropine; pralidoxime chloride Injectable;Intramuscular Meridian Medcl Manufacturing Change or Addition
Eliquis apixaban Tablet;Oral Bristol Myers Squibb Supplement
Faslodex fulvestrant Injectable;Intramuscular Astrazeneca Efficacy Supplement with Clinical Data to Support
Foradil formoterol fumarate Powder;Inhalation Novartis Manufacturing Change or Addition
Kengreal cangrelor Powder;Iv (Infusion) The Medicines Co Manufacturing Change or Addition
Magnesium Sulfate In Dextrose 5% In Plastic Container magnesium sulfate Injectable;Injection Hq Spclt Pharma Approval
Nymalize nimodipine Solution;Oral Arbor Pharms Llc Manufacturing Change or Addition
Prolia denosumab Injectable; Subcutaneous Amgen Labeling Revision
Rhinocort budesonide Spray, Metered;Nasal Astrazeneca Pharms Manufacturing Change or Addition
Rhinocort Allergy budesonide Spray, Metered;Nasal Astrazeneca Pharms Manufacturing Change or Addition
Ritonavir ritonavir Tablet;Oral Mylan Pharms Inc Tentative Approval
Venofer iron sucrose Injectable;Intravenous Luitpold Manufacturing Change or Addition
Xgeva denosumab Injectable; Subcutaneous Amgen Labeling Revision
Mar 022016
 

March 3, 2016

Mar 012016
 

March 1, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Clindesse clindamycin phosphate Cream;Vaginal Elan Pharma Intl Ltd Manufacturing Change or Addition
Faslodex fulvestrant Injectable;Intramuscular Astrazeneca Labeling Revision
Invega paliperidone Tablet, Extended Release;Oral Janssen Pharms Labeling Revision
Invega Sustenna paliperidone palmitate Suspension, Extended Release;Intramuscular Janssen Pharms Labeling Revision
Invega Trinza paliperidone palmitate Suspension, Extended Release;Intramuscular Janssen Pharms Labeling Revision
Maxipime cefepime hydrochloride Injectable;Injection Hospira Inc Labeling Revision
Palonosetron Hydrochloride palonosetron hydrochloride Injectable; Injection Dr Reddys Labs Ltd Approval
Risperdal risperidone Tablet;Oral Janssen Pharms Labeling Revision
Risperdal risperidone Solution;Oral Janssen Pharms Labeling Revision
Risperdal risperidone Tablet, Orally Disintegrating;Oral Janssen Pharms Labeling Revision
Risperdal Consta risperidone Injectable;Intramuscular Janssen Pharms Labeling Revision
Zocor simvastatin Tablet;Oral Merck Manufacturing Change or Addition
Zortress everolimus Tablet;Oral Novartis Manufacturing Change or Addition
Feb 292016
 

February 29, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Depo-Subq Provera 104 medroxyprogesterone acetate Injectable;Subcutaneous Pharmacia and Upjohn Manufacturing Change or Addition
Effexor Xr venlafaxine hydrochloride Capsule, Extended Release;Oral Wyeth Pharms Inc Labeling Revision
Eligard leuprolide acetate Injectable;Subcutaneous Tolmar Therap Labeling Revision
Eligard leuprolide acetate Injectable;Subcutaneous Tolmar Therap Labeling Revision
Eligard leuprolide acetate Injectable;Subcutaneous Tolmar Therap Labeling Revision
Eligard leuprolide acetate Injectable;Subcutaneous Tolmar Therap Labeling Revision
Fluticasone Propionate fluticasone propionate Spray, Metered;Nasal Apotex Technologies Approval
Gonal-F follitropin alfa/beta Injectable;Subcutaneous Emd Serono Manufacturing Change or Addition
Magnesium Sulfate magnesium sulfate Solution;Intramuscular, Intravenous Fresenius Kabi Usa Manufacturing Change or Addition
Qnasl beclomethasone dipropionate Aerosol, Metered;Nasal Teva Branded Pharm Manufacturing Change or Addition
Tecfidera dimethyl fumarate Capsule, Delayed Release;Oral Biogen Idec Inc Labeling Revision
Tetracaine Hydrochloride tetracaine hydrochloride Solution;Ophthalmic Alcon Res Ltd Approval
Vaniqa eflornithine hydrochloride Cream;Topical Skinmedica Manufacturing Change or Addition
Feb 252016
 

February 25, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Aleve naproxen sodium Tablet;Oral Bayer Manufacturing Change or Addition
Elelyso taliglucerase alfa Powder;Iv (Infusion) Pfizer Manufacturing Change or Addition
Elestat epinastine hydrochloride Solution/Drops;Ophthalmic Allergan Manufacturing Change or Addition
Premphase 14/14 estrogens, conjugated; medroxyprogesterone acetate Tablet;Oral-28 Wyeth Pharms Inc Manufacturing Change or Addition
Prempro estrogens, conjugated; medroxyprogesterone acetate Tablet;Oral-28 Wyeth Pharms Inc Manufacturing Change or Addition
Ritonavir ritonavir Tablet;Oral Aurobindo Pharma Ltd Tentative Approval
Solu-Cortef hydrocortisone sodium succinate Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Stalevo 100 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 125 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 150 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 200 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 50 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 75 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Survanta beractant Suspension;Intratracheal Abbvie Manufacturing Change or Addition
Truvada emtricitabine; tenofovir disoproxil fumarate Tablet;Oral Gilead Labeling Revision
Feb 252016
 
Feb 242016
 

February 24, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Aczone dapsone Gel; Topical Allergan Approval
Anoro Ellipta umeclidinium bromide; vilanterol trifenatate Powder;Inhalation Glaxosmithkline Labeling Revision
Depo-Provera medroxyprogesterone acetate Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Fosrenol lanthanum carbonate Tablet, Chewable;Oral Shire Llc Labeling Revision
Fosrenol lanthanum carbonate Powder;Oral Shire Dev Llc Labeling Revision
Incruse Ellipta umeclidinium bromide Powder;Inhalation Glaxo Grp England Efficacy Supplement with Clinical Data to Support
Lamotrigine lamotrigine Tablet, Orally Disintegrating;Oral Sciegen Pharms Inc Tentative Approval
Paricalcitol paricalcitol Capsule;Oral Lotus Pharm Co Ltd Approval
Qutenza capsaicin Patch;Topical Acorda Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container sodium chloride Solution;Irrigation Baxter Hlthcare Manufacturing Change or Addition
Ultravate halobetasol propionate Cream;Topical Ranbaxy Manufacturing Change or Addition