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
Feb 232016
 

February 23, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Complera emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate Tablet;Oral Gilead Sciences Inc Efficacy Supplement with Clinical Data to Support
Complera emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate Tablet;Oral Gilead Sciences Inc Labeling Revision
Dextrose 5% In Plastic Container dextrose Injectable;Injection Hospira Manufacturing Change or Addition
Diclofenac Potassium diclofenac potassium Capsule;Oral Bionpharma Inc Approval
Levetiracetam levetiracetam Tablet, Extended Release;Oral Intellipharmaceutics Approval
Lurasidone Hydrochloride lurasidone hydrochloride Tablet;Oral Emcure Pharms Ltd Tentative Approval
Norgestimate and Ethinyl Estradiol ethinyl estradiol; norgestimate Tablet;Oral-28 Glenmark Pharms Ltd Approval
Sodium Polystyrene Sulfonate sodium polystyrene sulfonate Powder;Oral, Rectal Belcher Pharms Llc Approval
Xeljanz tofacitinib Tablet, Extended Release;Oral Pfizer Inc Approval
Feb 222016
 

February 22, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Comtan entacapone Tablet;Oral Orion Pharma Labeling Revision
Dextrose 20% In Plastic Container dextrose Injectable;Injection Hospira Labeling Revision
Dextrose 30% In Plastic Container dextrose Injectable;Injection Hospira Labeling Revision
Dextrose 40% In Plastic Container dextrose Injectable;Injection Hospira Labeling Revision
Dextrose 50% In Plastic Container dextrose Injectable;Injection Hospira Labeling Revision
Dextrose 70% In Plastic Container dextrose Injectable;Injection Hospira Labeling Revision
Morphine Sulfate morphine sulfate Solution;Oral Lannett Holdings Inc Manufacturing Change or Addition
Opana Er oxymorphone hydrochloride Tablet, Extended Release;Oral Endo Pharms Manufacturing Change or Addition
Opsumit macitentan Tablet;Oral Actelion Pharms Ltd Supplement
Simponi Aria golimumab Injectable; Injection Janssen Biotech Labeling Revision
Somavert pegvisomant Injectable;Subcutaneous Pharmacia and Upjohn Manufacturing Change or Addition
Feb 192016
 

February 19, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Cefotaxime Sodium cefotaxime sodium Injectable;Injection Hospira Inc Approval
Depakote divalproex sodium Tablet, Delayed Release;Oral Abbvie Labeling Revision
Donepezil Hydrochloride donepezil hydrochloride Tablet;Oral Dexcel Pharma Approval
Gilenya fingolimod Capsule;Oral Novartis Labeling Revision
Humulin N insulin susp isophane recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Ibrance palbociclib Capsule;Oral Pfizer Inc Efficacy Supplement with Clinical Data to Support
Makena hydroxyprogesterone caproate Solution;Intramuscular Lumara Health Inc Manufacturing Change or Addition
Mysoline primidone Tablet;Oral Valeant Manufacturing Change or Addition
Nuvaring ethinyl estradiol; etonogestrel Ring;Vaginal Organon Usa Inc Manufacturing Change or Addition
Prezista darunavir ethanolate Tablet;Oral Janssen Prods Manufacturing Change or Addition
Primaxin cilastatin sodium; imipenem Powder;Intravenous Merck Manufacturing Change or Addition
Stribild cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate Tablet;Oral Gilead Sciences Inc Labeling Revision
Sumatriptan sumatriptan Spray;Nasal Lannett Approval
Tuzistra Xr chlorpheniramine polistirex; codeine polistirex Suspension, Extended Release;Oral Vernalis R and D Ltd Manufacturing Change or Addition
Feb 192016
 

February 19, 2016

Feb 182016
 

February 18, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Dantrolene Sodium dantrolene sodium Injectable;Injection Mylan Institutional Approval
Depacon valproate sodium Injectable;Injection Abbvie Labeling Revision
Depakene valproic acid Capsule;Oral Abbvie Labeling Revision
Depakene valproic acid Syrup;Oral Abbvie Labeling Revision
Depakote divalproex sodium Capsule, Delayed Rel Pellets;Oral Abbvie Labeling Revision
Doxycycline doxycycline Capsule;Oral Zydus Pharms Usa Inc Approval
Gabapentin gabapentin Capsule;Oral Sciegen Pharms Inc Approval
Odomzo sonidegib phosphate Capsule;Oral Novartis Pharms Corp Labeling Revision
Rizatriptan Benzoate rizatriptan benzoate Tablet;Oral Alkem Labs Ltd Approval
Sodium Polystyrene Sulfonate sodium polystyrene sulfonate Powder;Oral, Rectal Invatech Pharma Approval
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
Versacloz clozapine Suspension;Oral Jazz Pharms Iii Manufacturing Change or Addition
Vistaril hydroxyzine pamoate Capsule;Oral Pfizer Labeling Revision
Vistaril hydroxyzine pamoate Suspension;Oral Pfizer Labeling Revision