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U.S. Department of Health and Human Services

Drugs

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New and Generic Drug Approvals

 

April 21, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Atridox doxycycline hyclate System, Extended Release;Periodontal Tolmar Manufacturing Change or Addition
Caduet amlodipine besylate; atorvastatin calcium Tablet;Oral Pfizer Manufacturing Change or Addition
Claforan In Dextrose 5% In Plastic Container cefotaxime sodium Injectable;Injection Sanofi Aventis Us Manufacturing Change or Addition
Claforan In Sodium Chloride 0.9% In Plastic Container cefotaxime sodium Injectable;Injection Sanofi Aventis Us Manufacturing Change or Addition
Cyramza ramucirumab Injectable;Injection Eli Lilly and Co Approval
Endometrin progesterone Insert;Vaginal Ferring Manufacturing Change or Addition
Fanapt iloperidone Tablet;Oral Novartis Labeling Revision
Lotrisone betamethasone dipropionate; clotrimazole Cream;Topical Merck Sharp Dohme Labeling Revision
Procysbi cysteamine bitartrate Capsule, Delayed Release;Oral Raptor Pharms Manufacturing Change or Addition
Sprix ketorolac tromethamine Spray, Metered;Nasal Luitpold Labeling Revision
Ssd silver sulfadiazine Cream;Topical Dr Reddys La Manufacturing Change or Addition
Ssd Af silver sulfadiazine Cream;Topical Dr Reddys La Manufacturing Change or Addition
Uroxatral alfuzosin hydrochloride Tablet, Extended Release;Oral Covis Pharma Sarl Labeling Revision

 

April 18, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Edarbi azilsartan kamedoxomil Tablet;Oral Arbor Pharms Ireland Labeling Revision
Edarbyclor azilsartan kamedoxomil; chlorthalidone Tablet;Oral Arbor Pharms Ireland Labeling Revision
Minivelle estradiol Film, Extended Release;Transdermal Noven Manufacturing Change or Addition
Morphine Sulfate morphine sulfate Solution;Oral Roxane Manufacturing Change or Addition
Morphine Sulfate morphine sulfate Tablet; Oral Roxane Manufacturing Change or Addition
Nasonex mometasone furoate monohydrate Spray, Metered;Nasal Schering Plough Manufacturing Change or Addition
Precedex dexmedetomidine hydrochloride Injectable;Injection Hospira Manufacturing Change or Addition
Trokendi Xr topiramate Capsule, Extended Release;Oral Supernus Pharms Manufacturing Change or Addition
Zinecard dexrazoxane hydrochloride Injectable;Injection Pharmacia and Upjohn Labeling Revision

 

April 17, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Aranesp darbepoetin alfa Vial; Intravenous Amgen Labeling Revision
Aranesp darbepoetin alfa Vial; Subcutaneous Amgen Labeling Revision
Arzerra ofatumumab Injectable; Injection Glaxo Grp Ltd Efficacy Supplement with Clinical Data to Support
Coartem artemether; lumefantrine Tablet;Oral Novartis Manufacturing Change or Addition
Dulera formoterol fumarate; mometasone furoate Aerosol, Metered;Inhalation Merck Sharp Dohme Labeling Revision
Nicorette nicotine polacrilex Gum, Chewing;Buccal Glaxosmithkline Manufacturing Change or Addition
Nicorette nicotine polacrilex Gum, Chewing;Buccal Glaxosmithkline Manufacturing Change or Addition
Nicorette (Mint) nicotine polacrilex Gum, Chewing;Buccal Glaxosmithkline Manufacturing Change or Addition
Nicorette (Mint) nicotine polacrilex Gum, Chewing;Buccal Glaxosmithkline Manufacturing Change or Addition
Phenytoin phenytoin Tablet, Chewable, Tablet;Oral Taro Pharma Approval
Trental pentoxifylline Tablet, Extended Release;Oral Sanofi Aventis Us Labeling Revision
Vasostrict vasopressin Injectable; Injection Par Sterile Products Llc Approval
Viibryd vilazodone hydrochloride Tablet;Oral Forest Labs Inc Manufacturing Change or Addition
Vivitrol naltrexone For Suspension, Extended Release;Intramuscular Alkermes Manufacturing Change or Addition
Zytiga abiraterone acetate Tablet;Oral Janssen Biotech Manufacturing Change or Addition

 

April 16, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Allegra Allergy fexofenadine hydrochloride Tablet;Oral Sanofi Aventis Us Manufacturing Change or Addition
Allegra Hives fexofenadine hydrochloride Tablet;Oral Sanofi Aventis Us Manufacturing Change or Addition
Avinza morphine sulfate Capsule, Extended Release;Oral King Pharms Llc Labeling Revision
Butrans buprenorphine Film, Extended Release;Transdermal Purdue Pharma Lp Labeling Revision
Celexa citalopram hydrobromide Tablet;Oral Forest Labs Labeling Revision
Children's Allegra Allergy fexofenadine hydrochloride Tablet;Oral Sanofi Aventis Us Manufacturing Change or Addition
Children's Allegra Hives fexofenadine hydrochloride Tablet;Oral Sanofi Aventis Us Manufacturing Change or Addition
Dolophine Hydrochloride methadone hydrochloride Syrup;Oral Roxane Labeling Revision
Dolophine Hydrochloride methadone hydrochloride Tablet;Oral Roxane Labeling Revision
Duragesic-100 fentanyl Film, Extended Release;Transdermal Janssen Pharms Labeling Revision
Duragesic-12 fentanyl Film, Extended Release;Transdermal Janssen Pharms Labeling Revision
Duragesic-25 fentanyl Film, Extended Release;Transdermal Janssen Pharms Labeling Revision
Duragesic-50 fentanyl Film, Extended Release;Transdermal Janssen Pharms Labeling Revision
Duragesic-75 fentanyl Film, Extended Release;Transdermal Janssen Pharms Labeling Revision
Embeda morphine sulfate; naltrexone hydrochloride Capsule, Extended Release;Oral Alpharma Pharms Labeling Revision
Exalgo hydromorphone hydrochloride Tablet, Extended Release;Oral Mallinckrodt Inc Labeling Revision
Kadian morphine sulfate Capsule, Extended Release;Oral Watson Labs Inc Labeling Revision
Lo Minastrin Fe ethinyl estradiol; norethindrone acetate Tablet, Chewable, Tablet;Oral Warner Chilcott Manufacturing Change or Addition
Ms Contin morphine sulfate Tablet, Extended Release;Oral Purdue Pharma Lp Labeling Revision
Nucynta Er tapentadol hydrochloride Tablet, Extended Release;Oral Janssen Pharms Labeling Revision
Opana Er oxymorphone hydrochloride Tablet, Extended Release;Oral Endo Pharms Labeling Revision
Opana Er oxymorphone hydrochloride Tablet, Extended Release;Oral Endo Pharms Labeling Revision
Oxycontin oxycodone hydrochloride Tablet, Extended Release;Oral Purdue Pharma Lp Labeling Revision
Palladone hydromorphone hydrochloride Capsule, Extended Release;Oral Purdue Pharma Lp Labeling Revision
Pradaxa dabigatran etexilate mesylate Capsule;Oral Boehringer Ingelheim Manufacturing Change or Addition
Xulane ethinyl estradiol; norelgestromin Film, Extended Release;Transdermal Mylan Technologies Approval

 

April 15, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Eligard leuprolide acetate Injectable;Subcutaneous Tolmar Therap Manufacturing Change or Addition
Eszopiclone eszopiclone Tablet;Oral Dr Reddys Labs Ltd Approval
Eszopiclone eszopiclone Tablet;Oral Roxane Approval
Eszopiclone eszopiclone Tablet;Oral Glenmark Generics Approval
Excedrin (Migraine) acetaminophen; aspirin; caffeine Tablet;Oral Novartis Labeling Revision
Neurontin gabapentin Solution;Oral Parke Davis Manufacturing Change or Addition
Ramipril ramipril Capsule;Oral Accord Hlthcare Inc Approval
Sitagliptin Phosphate sitagliptin phosphate Tablet;Oral Watson Labs Inc Tentative Approval
Tanzeum albiglutide Injectable;Injection Glaxosmithkline Llc Approval

 

April 14, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Advair Diskus 100/50 fluticasone propionate; salmeterol xinafoate Powder;Inhalation Glaxo Grp Ltd Labeling Revision
Advair Diskus 250/50 fluticasone propionate; salmeterol xinafoate Powder;Inhalation Glaxo Grp Ltd Labeling Revision
Advair Diskus 500/50 fluticasone propionate; salmeterol xinafoate Powder;Inhalation Glaxo Grp Ltd Labeling Revision
Diazepam diazepam Concentrate;Oral Lannett Holdings Inc Approval
Doxil (Liposomal) doxorubicin hydrochloride Injectable, Liposomal;Injection Janssen Res and Dev Manufacturing Change or Addition
Esmolol Hydrochloride esmolol hydrochloride Injectable;Injection Hq Speciality Pharma Tentative Approval
Flovent Diskus 100 fluticasone propionate Powder;Inhalation Glaxo Grp Ltd Labeling Revision
Flovent Diskus 250 fluticasone propionate Powder;Inhalation Glaxo Grp Ltd Labeling Revision
Flovent Diskus 50 fluticasone propionate Powder;Inhalation Glaxo Grp Ltd Labeling Revision
Kadian morphine sulfate Capsule, Extended Release;Oral Watson Labs Inc Manufacturing Change or Addition
Minastrin 24 Fe ethinyl estradiol; norethindrone acetate Tablet, Chewable;Oral Warner Chilcott Llc Manufacturing Change or Addition
Nulojix belatacept Injectable; Injection Bristol Myers Squibb Labeling Revision
Selzentry maraviroc Tablet;Oral Viiv Hlthcare Manufacturing Change or Addition
Serevent salmeterol xinafoate Powder;Inhalation Glaxo Grp Ltd Labeling Revision
Sumatriptan Succinate sumatriptan succinate Injectable;Subcutaneous Agila Speclts Approval
Tarceva erlotinib hydrochloride Tablet;Oral Osi Pharms Labeling Revision
Zorvolex diclofenac Capsule;Oral Iroko Pharms Llc Manufacturing Change or Addition