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U.S. Department of Health and Human Services

Drugs

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New and Generic Drug Approvals

 

July 30, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Absorica isotretinoin Capsule;Oral Ranbaxy Labeling Revision
Amoxil amoxicillin For Suspension;Oral Dr Reddys Labs Inc Manufacturing Change or Addition
Belviq lorcaserin hydrochloride Tablet;Oral Eisai Inc Manufacturing Change or Addition
Canasa mesalamine Suppository;Rectal Forest Labs Inc Manufacturing Change or Addition
Diclegis doxylamine succinate; pyridoxine hydrochloride Tablet, Delayed Release;Oral Duchesnay Manufacturing Change or Addition
Excedrin (Migraine) acetaminophen; aspirin; caffeine Tablet;Oral Novartis Manufacturing Change or Addition
Humatrope somatropin recombinant Injectable;Injection Lilly Labeling Revision
Iclusig ponatinib hydrochloride Tablet;Oral Ariad Manufacturing Change or Addition
Jentadueto linagliptin; metformin hydrochloride Tablet;Oral Boehringer Ingelheim Efficacy Supplement with Clinical Data to Support
Quelicin succinylcholine chloride Injectable;Injection Hospira Manufacturing Change or Addition
Quelicin Preservative Free succinylcholine chloride Injectable;Injection Hospira Manufacturing Change or Addition

 

July 29, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Dextromethorphan Hydrobromide and Quinidine Sulfate dextromethorphan hydrobromide;quinidine sulfate Capsule;Oral Par Pharm Inc Tentative Approval
Epinephrine epinephrine Injectable;Injection Belcher Pharms Approval
Kalydeco ivacaftor Tablet;Oral Vertex Pharms Manufacturing Change or Addition
Korlym mifepristone Tablet;Oral Corcept Therap Manufacturing Change or Addition
Natrecor nesiritide recombinant For Solution;Intravenous Scios Llc Manufacturing Change or Addition
Prandimet metformin hydrochloride; repaglinide Tablet;Oral Novo Nordisk Inc Manufacturing Change or Addition
Viokace pancrelipase (amylase;lipase;protease) Tablet;Oral Forest Labs Inc Manufacturing Change or Addition

 

July 28, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Anafranil clomipramine hydrochloride Capsule;Oral Mallinckrodt Llc Labeling Revision
Aromasin exemestane Tablet;Oral Pharmacia and Upjohn Manufacturing Change or Addition
Caduet amlodipine besylate; atorvastatin calcium Tablet;Oral Pfizer Manufacturing Change or Addition
Cardura doxazosin mesylate Tablet;Oral Pfizer Manufacturing Change or Addition
Cardura Xl doxazosin mesylate Tablet, Extended Release;Oral Pfizer Manufacturing Change or Addition
Celebrex celecoxib Capsule;Oral Gd Searle Manufacturing Change or Addition
Chantix varenicline tartrate Tablet;Oral Pfizer Inc Manufacturing Change or Addition
Detrol tolterodine tartrate Tablet;Oral Pharmacia and Upjohn Manufacturing Change or Addition
Detrol La tolterodine tartrate Capsule, Extended Release;Oral Pharmacia and Upjohn Manufacturing Change or Addition
Diflucan fluconazole Tablet;Oral Pfizer Manufacturing Change or Addition
Diflucan fluconazole For Suspension;Oral Pfizer Manufacturing Change or Addition
Diflucan In Dextrose 5% In Plastic Container fluconazole Injectable;Injection Pfizer Manufacturing Change or Addition
Diflucan In Sodium Chloride 0.9% fluconazole Injectable;Injection Pfizer Manufacturing Change or Addition
Diflucan In Sodium Chloride 0.9% In Plastic Container fluconazole Injectable;Injection Pfizer Manufacturing Change or Addition
Exemestane exemestane Tablet;Oral Eirgen Pharma Ltd Approval
Imbruvica ibrutinib Capsule;Oral Pharmacyclics Inc Efficacy Supplement with Clinical Data to Support
Korlym mifepristone Tablet;Oral Corcept Therap Manufacturing Change or Addition
Minipress prazosin hydrochloride Capsule;Oral Pfizer Manufacturing Change or Addition
Norvasc amlodipine besylate Tablet;Oral Pfizer Manufacturing Change or Addition
Otezla apremilast Tablet;Oral Celgene Corp Manufacturing Change or Addition
Pamelor nortriptyline hydrochloride Solution;Oral Mallinckrodt Inc Labeling Revision
Pamelor nortriptyline hydrochloride Capsule;Oral Mallinckrodt Llc Labeling Revision
Taclonex betamethasone dipropionate; calcipotriene hydrate Ointment;Topical Leo Pharma As Labeling Revision
Taclonex betamethasone dipropionate; calcipotriene hydrate Suspension;Topical Leo Pharma As Labeling Revision
Technescan Mag3 technetium tc-99m mertiatide kit Injectable;Injection Mallinckrodt Manufacturing Change or Addition
Tofranil-Pm imipramine pamoate Capsule;Oral Mallinckrodt Inc Labeling Revision
Vascepa icosapent ethyl Capsule;Oral Amarin Pharms Manufacturing Change or Addition
Victrelis boceprevir Capsule;Oral Merck Sharp Dohme Labeling Revision
Zyvox linezolid Tablet;Oral Pharmacia and Upjohn Manufacturing Change or Addition
Zyvox linezolid Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Zyvox linezolid For Suspension;Oral Pharmacia and Upjohn Manufacturing Change or Addition

 

July 25, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Acticlate doxycycline hyclate Tablet;Oral Aqua Pharms Approval
Adrenaclick epinephrine Injectable;Intramuscular, Subcutaneous Amedra Pharms Labeling Revision
Alinia nitazoxanide For Suspension;Oral Romark Manufacturing Change or Addition
Apokyn apomorphine hydrochloride Injectable;Subcutaneous Us Worldmeds Labeling Revision
Azactam In Plastic Container aztreonam Injectable;Injection Bristol Myers Squibb Manufacturing Change or Addition
Biaxin clarithromycin Tablet;Oral Abbvie Labeling Revision
Biaxin clarithromycin For Suspension;Oral Abbvie Labeling Revision
Biaxin Xl clarithromycin Tablet, Extended Release;Oral Abbvie Labeling Revision
Children's Claritin loratadine Tablet, Chewable;Oral Schering Plough Labeling Revision
Habitrol nicotine Film, Extended Release; Transdermal Novartis Labeling Revision
Habitrol nicotine Film, Extended Release;Transdermal Novartis Labeling Revision
Jakafi ruxolitinib phosphate Tablet;Oral Incyte Corp Efficacy Supplement with Clinical Data to Support
Lastacaft alcaftadine Solution/Drops;Ophthalmic Allergan Manufacturing Change or Addition
Mestinon pyridostigmine bromide Tablet, Extended Release;Oral Valeant Pharms Llc Manufacturing Change or Addition
Pradaxa dabigatran etexilate mesylate Capsule;Oral Boehringer Ingelheim Manufacturing Change or Addition
Prevantics Maxi Swabstick chlorhexidine gluconate; isopropyl alcohol Swab;Topical Prof Dspls Labeling Revision
Prevantics Swab chlorhexidine gluconate; isopropyl alcohol Swab;Topical Prof Dspls Labeling Revision
Prevantics Swabstick chlorhexidine gluconate; isopropyl alcohol Swab;Topical Prof Dspls Labeling Revision
Twinject 0.15 epinephrine Injectable;Intramuscular, Subcutaneous Amedra Pharms Labeling Revision
Twinject 0.3 epinephrine Injectable;Intramuscular, Subcutaneous Amedra Pharms Labeling Revision

 

July 24, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Adderall Xr 10 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate Capsule, Extended Release;Oral Shire Labeling Revision
Adderall Xr 15 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate Capsule, Extended Release;Oral Shire Labeling Revision
Adderall Xr 20 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate Capsule, Extended Release;Oral Shire Labeling Revision
Adderall Xr 25 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate Capsule, Extended Release;Oral Shire Labeling Revision
Adderall Xr 30 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate Capsule, Extended Release;Oral Shire Labeling Revision
Adderall Xr 5 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate Capsule, Extended Release;Oral Shire Labeling Revision
Crixivan indinavir sulfate Capsule;Oral Merck Sharp Dohme Labeling Revision
Fortical calcitonin salmon recombinant Spray, Metered;Nasal Upsher Smith Manufacturing Change or Addition

 

July 23, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Cardene nicardipine hydrochloride Injectable;Injection Chiesi Usa Inc Labeling Revision
Cardene In 0.83% Sodium Chloride In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Labeling Revision
Cardene In 0.86% Sodium Chloride In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Labeling Revision
Cardene In 4.8% Dextrose In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Labeling Revision
Cardene In 5.0% Dextrose In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Labeling Revision
Edarbi azilsartan kamedoxomil Tablet;Oral Arbor Pharms Ireland Labeling Revision
Edarbyclor azilsartan kamedoxomil; chlorthalidone Tablet;Oral Arbor Pharms Ireland Labeling Revision
Flonase Allergy Relief fluticasone propionate Spray;Metered Glaxosmithkline Cons Approval
Hydrochlorothiazide hydrochlorothiazide Tablet;Oral Sciegen Pharms Inc Approval
Targiniq Er oxycodone hydrochloride;naloxone hydrochloride Tablet, Extended Release;Oral Purdue Pharma Lp Approval
Terazol 3 terconazole Suppository;Vaginal Janssen Pharms Labeling Revision
Terazol 3 terconazole Cream;Vaginal Janssen Pharms Labeling Revision
Terazol 7 terconazole Cream;Vaginal Janssen Pharms Labeling Revision
Testosterone testosterone Gel;Transdermal Teva Pharms Labeling Revision
Zydelig idelalisib Tablet;Oral Gilead Sciences Inc Approval
Zydelig idelalisib Tablet;Oral Gilead Sciences Inc Approval

 

July 22, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Claritin Hives Relief Reditab loratadine Tablet, Orally Disintegrating;Oral Schering Plough Labeling Revision
Claritin Reditabs loratadine Tablet, Orally Disintegrating;Oral Schering Plough Labeling Revision
Claritin Reditabs loratadine Tablet, Orally Disintegrating;Oral Schering Plough Labeling Revision
Cytoxan cyclophosphamide Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Cytoxan (Lyophilized) cyclophosphamide Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Desonate desonide Gel;Topical Bayer Hlthcare Labeling Revision
Lotensin Hct benazepril hydrochloride; hydrochlorothiazide Tablet;Oral Us Pharms Holdings I Manufacturing Change or Addition
Lyophilized Cytoxan cyclophosphamide Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Otezla apremilast Tablet;Oral Celgene Corp Manufacturing Change or Addition
Prohance Multipack gadoteridol Injectable;Injection Bracco Labeling Revision
Ryanodex dantrolene sodium Suspension;Injectable Eagle Pharms Approval
Solu-Cortef hydrocortisone sodium succinate Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Solu-Medrol methylprednisolone sodium succinate Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Tacrolimus tacrolimus Capsule;Oral Strides Arcolab Ltd Approval
Teveten eprosartan mesylate Tablet;Oral Abbvie Labeling Revision
Teveten Hct eprosartan mesylate; hydrochlorothiazide Tablet;Oral Abbvie Labeling Revision
Xeloda capecitabine Tablet;Oral Hoffmann La Roche Manufacturing Change or Addition
Zoledronic Acid zoledronic acid Injectable;Injection Sun Pharma Global Tentative Approval

 

July 21, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride Syrup;Oral Vintage Pharms Approval
Fiorinal aspirin; butalbital; caffeine Capsule;Oral Watson Labs Inc Manufacturing Change or Addition
Fiorinal aspirin; butalbital; caffeine Tablet;Oral Watson Labs Inc Manufacturing Change or Addition
Pennsaid diclofenac sodium Solution;Topical Mallinckrodt Inc Manufacturing Change or Addition
Qvar 40 beclomethasone dipropionate Aerosol, Metered;Inhalation Teva Branded Pharm Labeling Revision
Qvar 80 beclomethasone dipropionate Aerosol, Metered;Inhalation Teva Branded Pharm Labeling Revision

 

July 20, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Flomax tamsulosin hydrochloride Capsule;Oral Boehringer Ingelheim Labeling Revision