Drugs

New and Generic Drug Approvals

September 23, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Amjevita adalimumab-atto Injectable;Injection Amgen Inc Approval

 

September 22, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Femcon Fe ethinyl estradiol; norethindrone Tablet, Chewable;Oral Apil Labeling Revision
Furosemide furosemide Injectable;Injection Hospira Labeling Revision
Habitrol nicotine Film, Extended Release; Transdermal Dr Reddys Labs Inc Manufacturing Change or Addition
Habitrol nicotine Film, Extended Release;Transdermal Dr Reddys Labs Inc Manufacturing Change or Addition
Humalog insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Kwikpen insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Pen insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humulin R insulin human Solution;Subcutaneous Lilly Manufacturing Change or Addition
Humulin R insulin recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Humulin R Kwikpen insulin human Solution;Subcutaneous Lilly Manufacturing Change or Addition
Humulin R Pen insulin recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Jublia efinaconazole Solution;Topical Dow Pharm Labeling Revision
Methylphenidate Hydrochloride methylphenidate hydrochloride Tablet, Extended Release;Oral Actavis Labs Fl Inc Tentative Approval
Nasacort Allergy 24 Hour triamcinolone acetonide Spray, Metered;Nasal Sanofi Aventis Us Labeling Revision
Saxenda liraglutide recombinant Solution;Subcutaneous Novo Nordisk Inc Labeling Revision
Tysabri natalizumab Vial; Single-Use Biogen Idec Supplement

 

September 21, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Aciphex rabeprazole sodium Tablet, Delayed Release;Oral Eisai Inc Manufacturing Change or Addition
Amidate etomidate Injectable;Injection Hospira Manufacturing Change or Addition
Drospirenone and Ethinyl Estradiol drospirenone; ethinyl estradiol Tablet;Oral-28 Apotex Inc Approval
Infuvite Pediatric (Pharmacy Bulk Package) ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k Injectable;Iv (Infusion) Sandoz Manufacturing Change or Addition
Mannitol 10% mannitol Injectable;Injection Hospira Manufacturing Change or Addition
Mannitol 15% mannitol Injectable;Injection Hospira Manufacturing Change or Addition
Mannitol 20% mannitol Injectable;Injection Hospira Manufacturing Change or Addition
Mannitol 25% mannitol Injectable;Injection Hospira Manufacturing Change or Addition
Mannitol 5% mannitol Injectable;Injection Hospira Manufacturing Change or Addition
Ms Contin morphine sulfate Tablet, Extended Release;Oral Purdue Pharma Lp Manufacturing Change or Addition
Orfadin nitisinone Capsule;Oral Swedish Orphan Manufacturing Change or Addition
Prevacid lansoprazole Tablet, Delayed Release, Orally Disintegrating;Oral Takeda Pharms Usa Manufacturing Change or Addition
Sancuso granisetron Film, Extended Release;Transdermal Kyowa Kirin Manufacturing Change or Addition
Tagrisso osimertinib mesylate Tablet;Oral Astrazeneca Pharms Manufacturing Change or Addition
Trimethoprim trimethoprim Tablet;Oral Mayne Pharma Manufacturing Change or Addition
Zydelig idelalisib Tablet;Oral Gilead Sciences Inc Labeling Revision

 

September 20, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Alecensa alectinib hydrochloride Capsule;Oral Hoffmann-La Roche Manufacturing Change or Addition
Anzemet dolasetron mesylate Tablet;Oral Us Pharm Holdings Manufacturing Change or Addition
Benicar Hct hydrochlorothiazide; olmesartan medoxomil Tablet;Oral Daiichi Sankyo Manufacturing Change or Addition
Bicnu carmustine Injectable;Injection Emcure Pharms Ltd Manufacturing Change or Addition
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride Syrup;Oral Acella Pharms Llc Approval
Bunavail buprenorphine hydrochloride; naloxone hydrochloride Film;Buccal Biodelivery Sci Intl Manufacturing Change or Addition
Epaned enalapril maleate Solution;Oral Silvergate Pharms Approval
Invokamet Xr canagliflozin;metformin hydrochloride Tablet, Extended Release;Oral Janssen Pharms Approval
Lotronex alosetron hydrochloride Tablet;Oral Sebela Ireland Ltd Manufacturing Change or Addition
Spironolactone spironolactone Tablet;Oral Accord Hlthcare Inc Approval
Valsartan valsartan Tablet;Oral Macleods Pharms Ltd Approval
Victoza liraglutide recombinant Solution;Subcutaneous Novo Nordisk Inc Supplement

 

September 19, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Argatroban In Sodium Chloride argatroban Injectable;Iv (Infusion) Sandoz Manufacturing Change or Addition
Avandia rosiglitazone maleate Tablet;Oral Sb Pharmco Labeling Revision
Bicnu carmustine Injectable;Injection Emcure Pharms Ltd Manufacturing Change or Addition
Buprenorphine Hydrochloride and Naloxone Hydrochloride buprenorphine hydrochloride; naloxone hydrochloride Tablet;Sublingual Kremers Urban Pharms Approval
Darifenacin Hydrobromide darifenacin hydrobromide Tablet, Extended Release;Oral Aurobindo Pharma Ltd Approval
Dexmedetomidine Hydrochloride dexmedetomidine hydrochloride Solution;Iv (Infusion) Hq Spclt Pharma Efficacy Supplement with Clinical Data to Support
Dolutegravir dolutegravir Tablet;Oral Aurobindo Pharma Ltd Tentative Approval
Exondys 51 eteplirsen Injectable;Injection Sarepta Therapeutics Inc Approval
Exparel bupivacaine Injectable, Liposomal;Injection Pacira Pharms Inc Manufacturing Change or Addition
Furosemide furosemide Injectable;Injection Fresenius Kabi Usa Labeling Revision
Lescol fluvastatin sodium Capsule;Oral Novartis Manufacturing Change or Addition
Loprox ciclopirox Shampoo;Topical Medicis Manufacturing Change or Addition
Patanase olopatadine hydrochloride Spray, Metered;Nasal Alcon Pharms Ltd Manufacturing Change or Addition
Tivicay dolutegravir sodium Tablet;Oral Viiv Hlthcare Manufacturing Change or Addition
Xiaflex collagenase clostridium histolyticum Solution; Injection Auxilium Pharms Labeling Revision

 

September 16, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Adrenalin epinephrine Injectable;Intramuscular, Subcutaneous Par Sterile Products Manufacturing Change or Addition
Avage tazarotene Cream;Topical Allergan Labeling Revision
Famvir famciclovir Tablet;Oral Novartis Labeling Revision
Kyleena levonorgestrel System;Releasing Intrauterine Bayer Healthcare Pharms Approval
Levetiracetam levetiracetam Injectable;Iv (Infusion) Mylan Labs Ltd Approval
Optison albumin human Injectable;Injection Ge Healthcare Labeling Revision
Plavix clopidogrel bisulfate Tablet;Oral Sanofi Aventis Us Labeling Revision
Sivextro tedizolid phosphate Tablet;Oral Cubist Pharms Llc Labeling Revision
Tazorac tazarotene Cream;Topical Allergan Labeling Revision

 

September 15, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Aptivus tipranavir Capsule;Oral Boehringer Ingelheim Labeling Revision
Aptivus tipranavir Solution;Oral Boehringer Ingelheim Labeling Revision
Crixivan indinavir sulfate Capsule;Oral Merck Sharp Dohme Labeling Revision
Duopa carbidopa; levodopa Suspension;Enteral Abbvie Inc Labeling Revision
Estring estradiol Insert, Extended Release;Vaginal Pharmacia and Upjohn Manufacturing Change or Addition
Forteo teriparatide recombinant human Injectable;Subcutaneous Lilly Manufacturing Change or Addition
Fusilev levoleucovorin calcium Powder;Iv (Infusion) Spectrum Pharms Manufacturing Change or Addition
Fusilev levoleucovorin calcium Solution;Iv (Infusion) Spectrum Pharms Manufacturing Change or Addition
Genvoya cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate Tablet;Oral Gilead Sciences Inc Labeling Revision
Hylenex Recombinant hyaluronidase recombinant human Injectable;Injection Halozyme Therap Manufacturing Change or Addition
Invirase saquinavir mesylate Capsule;Oral Hoffmann La Roche Labeling Revision
Invirase saquinavir mesylate Tablet;Oral Hoffmann-La Roche Labeling Revision
Kaletra lopinavir; ritonavir Capsule;Oral Abbvie Labeling Revision
Kaletra lopinavir; ritonavir Solution;Oral Abbvie Labeling Revision
Kaletra lopinavir; ritonavir Tablet;Oral Abbvie Labeling Revision
Lexiva fosamprenavir calcium Tablet;Oral Viiv Hlthcare Labeling Revision
Lexiva fosamprenavir calcium Suspension;Oral Viiv Hlthcare Labeling Revision
Norvir ritonavir Solution;Oral Abbvie Labeling Revision
Norvir ritonavir Capsule;Oral Abbvie Labeling Revision
Norvir ritonavir Tablet;Oral Abbvie Labeling Revision
Oxytocin oxytocin Injectable;Injection Fresenius Kabi Usa Manufacturing Change or Addition
Premarin estrogens, conjugated Injectable;Injection Wyeth Pharms Inc Manufacturing Change or Addition
Premarin estrogens, conjugated Cream;Topical, Vaginal Wyeth Pharms Inc Manufacturing Change or Addition
Prezista darunavir ethanolate Tablet;Oral Janssen Prods Labeling Revision
Prezista darunavir ethanolate Suspension;Oral Janssen Prods Labeling Revision
Reyataz atazanavir sulfate Capsule;Oral Bristol Myers Squibb Labeling Revision
Reyataz atazanavir sulfate Powder;Oral Bristol Myers Squibb Labeling Revision
Savaysa edoxaban tosylate Tablet;Oral Daiichi Sankyo Labeling Revision
Stribild cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate Tablet;Oral Gilead Sciences Inc Labeling Revision
Viracept nelfinavir mesylate Powder;Oral Agouron Labeling Revision
Viracept nelfinavir mesylate Tablet;Oral Agouron Labeling Revision
Viracept nelfinavir mesylate Tablet;Oral Agouron Labeling Revision
Zykadia ceritinib Capsule;Oral Novartis Pharms Corp Manufacturing Change or Addition

 

September 14, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Cerezyme imiglucerase Injectable;Injection Genzyme Manufacturing Change or Addition
Cipro ciprofloxacin hydrochloride Tablet;Oral Bayer Hlthcare Labeling Revision
Cipro ciprofloxacin For Suspension;Oral Bayer Hlthcare Labeling Revision
Seebri glycopyrrolate Powder;Inhalation Novartis Pharms Corp Manufacturing Change or Addition
Yosprala aspirin;omeprazole Tablet, Delayed Release;Oral Aralez Pharms Inc Approval

Page Last Updated: 09/23/2016
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