Drugs

New and Generic Drug Approvals

March 27, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Amturnide aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide Tablet;Oral Novartis Labeling Revision
Aptivus tipranavir Capsule;Oral Boehringer Ingelheim Labeling Revision
Aptivus tipranavir Solution;Oral Boehringer Ingelheim Labeling Revision
Cordarone amiodarone hydrochloride Tablet;Oral Wyeth Pharms Inc Labeling Revision
Emsam selegiline Film, Extended Release;Transdermal Somerset Labeling Revision
Eovist gadoxetate disodium Solution;Intravenous Bayer Hlthcare Efficacy Supplement with Clinical Data to Support
Invirase saquinavir mesylate Capsule;Oral Hoffmann La Roche Labeling Revision
Invirase saquinavir mesylate Tablet;Oral Hoffman 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
Mirapex pramipexole dihydrochloride Tablet;Oral Boehringer Ingelheim Labeling Revision
Mirapex Er pramipexole dihydrochloride Tablet, Extended Release;Oral Boehringer Ingelheim Labeling Revision
Norvir ritonavir Capsule;Oral Abbvie Labeling Revision
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
Saxenda liraglutide recombinant Solution;Subcutaneous Novo Nordisk Inc Labeling Revision
Sustiva efavirenz Capsule;Oral Bristol Myers Squibb Labeling Revision
Sustiva efavirenz Tablet;Oral Bristol Myers Squibb Labeling Revision
Tekamlo aliskiren hemifumarate; amlodipine besylate Tablet;Oral Novartis Labeling Revision
Tekturna aliskiren hemifumarate Tablet;Oral Novartis Labeling Revision
Tekturna Hct aliskiren hemifumarate; hydrochlorothiazide Tablet;Oral Novartis 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

 

March 26, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Actonel risedronate sodium Tablet;Oral Warner Chilcott Llc Labeling Revision
Actonel With Calcium (Copackaged) calcium carbonate; risedronate sodium Tablet, Tablet;Oral Warner Chilcott Labeling Revision
Atelvia risedronate sodium Tablet, Delayed Release;Oral Warner Chilcott Llc Labeling Revision
Brilinta ticagrelor Tablet;Oral Astrazeneca Lp Labeling Revision
Tolcapone tolcapone Tablet;Oral Par Pharm Inc Approval
Viagra sildenafil citrate Tablet;Oral Pfizer Ireland Labeling Revision

 

March 25, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Enbrel etanercept Syringe Immunex Labeling Revision
Enbrel etanercept Vial; Subcutaneous Immunex Labeling Revision
Eylea aflibercept Injectable; Injection Regeneron Pharmaceuticals Efficacy Supplement with Clinical Data to Support
Viekira Pak (Copackaged) dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir Tablet, Tablet;Oral Abbvie Inc Labeling Revision
Vimovo esomeprazole magnesium; naproxen Tablet, Delayed Release;Oral Horizon Pharma Labeling Revision

 

March 24, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
H.P. Acthar Gel corticotropin Injectable;Injection Questcor Pharms Labeling Revision
Lamictal lamotrigine Tablet;Oral Glaxosmithkline Llc Labeling Revision
Lamictal Cd lamotrigine Tablet, Chewable;Oral Glaxosmithkline Llc Labeling Revision
Lamictal Odt lamotrigine Tablet, Orally Disintegrating;Oral Glaxosmithkline Llc Labeling Revision
Lamictal Xr lamotrigine Tablet, Extended Release;Oral Glaxosmithkline Llc Labeling Revision

 

March 23, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Argatroban Injection argatroban Injectable;Injection Fresenius Kabi Usa Approval
Caduet amlodipine besylate; atorvastatin calcium Tablet;Oral Pfizer Labeling Revision
Cardizem La diltiazem hydrochloride Tablet, Extended Release;Oral Valeant Intl Labeling Revision
Claforan cefotaxime sodium Injectable;Injection Sanofi Aventis Us Labeling Revision
Claforan In Dextrose 5% In Plastic Container cefotaxime sodium Injectable;Injection Sanofi Aventis Us Labeling Revision
Claforan In Sodium Chloride 0.9% In Plastic Container cefotaxime sodium Injectable;Injection Sanofi Aventis Us Labeling Revision
Epivir lamivudine Tablet;Oral Viiv Hlthcare Efficacy Supplement with Clinical Data to Support
Epivir lamivudine Solution;Oral Viiv Hlthcare Efficacy Supplement with Clinical Data to Support
Norvasc amlodipine besylate Tablet;Oral Pfizer Labeling Revision
Rhinocort budesonide Spray, Metered;Nasal Astrazeneca Pharms Efficacy Supplement with Clinical Data to Support
Ziagen abacavir sulfate Tablet;Oral Viiv Hlthcare Efficacy Supplement with Clinical Data to Support
Ziagen abacavir sulfate Solution;Oral Viiv Hlthcare Efficacy Supplement with Clinical Data to Support

 

March 20, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Arnuity Ellipta fluticasone furoate Powder;Inhalation Glaxosmithkline Labeling Revision
Cenestin estrogens, conjugated synthetic a Tablet;Oral Teva Branded Pharm Labeling Revision
Enbrel etanercept Syringe Immunex Supplement
Enbrel etanercept Vial; Subcutaneous Immunex Supplement
Harvoni ledipasvir; sofosbuvir Tablet;Oral Gilead Sciences Inc Labeling Revision
Rocephin ceftriaxone sodium Injectable;Injection Hoffmann La Roche Labeling Revision
Rocephin ceftriaxone sodium Injectable;Intramuscular, Intravenous Hoffmann La Roche Labeling Revision
Rocephin Kit ceftriaxone sodium; lidocaine Injectable;Injection Hoffmann La Roche Labeling Revision
Sovaldi sofosbuvir Tablet;Oral Gilead Sciences Inc Labeling Revision
Symlin pramlintide acetate Injectable;Subcutaneous Astrazeneca Ab Labeling Revision
Xalkori crizotinib Capsule;Oral Pf Prism Cv Labeling Revision
Zytiga abiraterone acetate Tablet;Oral Janssen Biotech Efficacy Supplement with Clinical Data to Support

 

March 19, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Bactroban mupirocin Ointment;Topical Glaxosmithkline Labeling Revision
Bactroban mupirocin calcium Cream;Topical Glaxosmithkline Labeling Revision
Bivalirudin bivalirudin Injectable;Injection Sagent Pharms Tentative Approval
Cipro ciprofloxacin Injectable;Injection Bayer Hlthcare Labeling Revision
Cipro In Dextrose 5% In Plastic Container ciprofloxacin Injectable;Injection Bayer Hlthcare Labeling Revision
Coartem artemether; lumefantrine Tablet;Oral Novartis Labeling Revision
Xeloda capecitabine Tablet;Oral Hoffmann La Roche Labeling Revision
Yervoy ipilimumab Injectable; Injection Bristol Myers Squibb Labeling Revision
Zoledronic Acid zoledronic acid Injectable;Iv (Infusion) Hospira Inc Approval

 

March 18, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Boniva ibandronate sodium Tablet;Oral Hoffmann La Roche Labeling Revision
Boniva ibandronate sodium Injectable;Intravenous Roche Labeling Revision
Cefobid cefoperazone sodium Injectable;Injection Pfizer Labeling Revision
Didronel etidronate disodium Tablet;Oral Procter and Gamble Labeling Revision
Imodium A-D loperamide hydrochloride Solution;Oral Mcneil Cons Labeling Revision
Imodium A-D loperamide hydrochloride Suspension;Oral Mcneil Cons Labeling Revision
Imodium Multi-Symptom Relief loperamide hydrochloride; simethicone Tablet;Oral Mcneil Cons Labeling Revision
Intuniv guanfacine hydrochloride Tablet, Extended Release;Oral Shire Efficacy Supplement with Clinical Data to Support
Metoprolol Tartrate metoprolol tartrate Tablet;Oral Mylan Chemistry New Strength
Pegasys peginterferon alfa-2a Syringe Hoffman-La Roche Labeling Revision
Pegasys peginterferon alfa-2a Vial; Subcutaneous Hoffman-La Roche Labeling Revision
Tenofovir Disoproxil Fumarate tenofovir disoproxil fumarate Tablet;Oral Teva Pharms Usa Approval

 

March 17, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Cholbam cholic acid Capsule;Oral Asklepion Pharmaceuticals Llc Approval
Kalydeco ivacaftor Granule;Oral Vertical Pharms Llc Approval
Lacosamide lacosamide Tablet;Oral Aurobindo Pharma Ltd Tentative Approval
Perjeta pertuzumab Vial; Single-Use Genentech Efficacy Supplement with Clinical Data to Support
Signifor pasireotide diaspartate Solution;Subcutaneous Novartis Labeling Revision

 

March 16, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Actoplus Met Xr metformin hydrochloride; pioglitazone hydrochloride Tablet, Extended Release;Oral Takeda Pharms Usa Manufacturing Change or Addition
Augmentin Es-600 amoxicillin; clavulanate potassium For Suspension;Oral Dr Reddys Labs Inc Labeling Revision
Avandaryl glimepiride; rosiglitazone maleate Tablet;Oral Sb Pharmco Labeling Revision
Benzamycin Pak benzoyl peroxide; erythromycin Gel;Topical Valeant Luxembourg Manufacturing Change or Addition
Celecoxib celecoxib Capsule;Oral Lupin Ltd Approval
Chlorhexidine Gluconate chlorhexidine gluconate Cloth;Topical Sage Prods Manufacturing Change or Addition
Contrave bupropion hydrochloride; naltrexone hydrochloride Tablet, Extended Release;Oral Takeda Pharms Usa Manufacturing Change or Addition
Depocyt cytarabine Injectable, Liposomal;Injection Pacira Pharms Inc Manufacturing Change or Addition
Duetact glimepiride; pioglitazone hydrochloride Tablet;Oral Takeda Pharms Usa Labeling Revision
Feraheme ferumoxytol Solution;Intravenous Amag Pharms Inc Labeling Revision
Fluoxetine Hydrochloride fluoxetine hydrochloride Capsule;Oral Sciegen Pharms Inc Approval
Invanz ertapenem sodium Injectable;Intramuscular, Iv (Infusion) Merck Sharp Dohme Manufacturing Change or Addition
Mephyton phytonadione Tablet;Oral Valeant Pharms Manufacturing Change or Addition
Norvir ritonavir Solution;Oral Abbvie Labeling Revision
Norvir ritonavir Capsule;Oral Abbvie Labeling Revision
Norvir ritonavir Tablet;Oral Abbvie Labeling Revision
Tamiflu oseltamivir phosphate For Suspension;Oral Roche Manufacturing Change or Addition
Viibryd vilazodone hydrochloride Tablet;Oral Forest Labs Inc Efficacy Supplement with Clinical Data to Support
Zecuity sumatriptan succinate System;Iontophoresis Teva Branded Pharm Manufacturing Change or Addition
Zinacef cefuroxime sodium Injectable;Injection Covis Injectables Manufacturing Change or Addition
Zinacef cefuroxime sodium Injectable;Intramuscular, Intravenous Covis Injectables Manufacturing Change or Addition

 

Page Last Updated: 03/30/2015
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