Drugs
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New and Generic Drug Approvals
May 17, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Angiomax | bivalirudin | Injectable; Intravenous | Medicines Co | Labeling Revision |
| Lamivudine; Tenofovir Disoproxil Fumarate | lamivudine; tenofovir disoproxil fumarate | Tablet; Oral | Ranbaxy Labs Ltd | Tentative Approval |
| Levetiracetam | levetiracetam | Tablet, Extended Release; Oral | Apotex Inc | Tentative Approval |
| Tasigna | nilotinib hydrochloride monohydrate | Capsule; Oral | Novartis | Labeling Revision |
| Ultravate | halobetasol propionate | Ointment; Topical | Ranbaxy | Manufacturing Change or Addition |
May 16, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Estradiol | estradiol | Film, Extended Release; Transdermal | Novartis | Labeling Revision |
| Habitrol | nicotine | Film, Extended Release; Transdermal | Novartis | Manufacturing Change or Addition |
| Inspra | eplerenone | Tablet; Oral | Gd Searle Llc | Labeling Revision |
| Lanoxin | digoxin | Injectable; Injection | Covis Pharma | Labeling Revision |
| Lanoxin Pediatric | digoxin | Injectable; Injection | Covis Pharma | Labeling Revision |
| Lantus | insulin glargine recombinant | Injectable; Injection | Sanofi Aventis Us | Labeling Revision |
| Letrozole | letrozole | Tablet; Oral | Jiangsu Hengrui Med | Approval |
| Pegasys | peginterferon alfa-2a | Syringe | Hoffman-La Roche | Labeling Revision |
| Pegasys | peginterferon alfa-2a | Vial; Subcutaneous | Hoffman-La Roche | Labeling Revision |
| Rivastigmine Tartrate | rivastigmine tartrate | Capsule; Oral | Apotex Inc | Approval |
| Tramadol Hydrochloride | tramadol hydrochloride | Tablet; Oral | Accord Hlthcare Inc | Approval |
| Vivelle-Dot | estradiol | Film, Extended Release; Transdermal | Novartis | Labeling Revision |
May 15, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Accolate | zafirlukast | Tablet; Oral | Astrazeneca | Manufacturing Change or Addition |
| Altoprev | lovastatin | Tablet, Extended Release; Oral | Andrx Labs Llc | Manufacturing Change or Addition |
| Colcrys | colchicine | Tablet; Oral | Takeda Pharms Usa | Manufacturing Change or Addition |
| Durezol | difluprednate | Emulsion; Ophthalmic | Alcon Pharms Ltd | Labeling Revision |
| Infergen | interferon alfacon-1 | Vial | Intermune Pharms | Labeling Revision |
| Kombiglyze Xr | metformin hydrochloride; saxagliptin hydrochloride | Tablet, Extended Release; Oral | Bristol Myers Squibb | Manufacturing Change or Addition |
| Norditropin | somatropin recombinant | Injectable; Injection | Novo Nordisk Inc | Manufacturing Change or Addition |
| Norditropin Flexpro | somatropin recombinant | Injectable; Injection | Novo Nordisk Inc | Manufacturing Change or Addition |
| Norditropin Nordiflex | somatropin recombinant | Injectable; Injection | Novo Nordisk Inc | Manufacturing Change or Addition |
| Pegintron | peginterferon alfa-2b | Syringe | Schering | Labeling Revision |
| Pegintron | peginterferon alfa-2b | Vial | Schering | Labeling Revision |
| Prilosec | omeprazole | Capsule, Delayed Rel Pellets; Oral | Astrazeneca | Labeling Revision |
| Pulmicort Respules | budesonide | Suspension; Inhalation | Astrazeneca | Manufacturing Change or Addition |
| Quillivant Xr | methylphenidate hydrochloride | For Suspension, Extended Release; Oral | Nextwave Pharms | Manufacturing Change or Addition |
| Rocaltrol | calcitriol | Solution; Oral | Validus Pharms | Manufacturing Change or Addition |
| Simponi | golimumab | Injectable; Injection | Centocor Ortho Biotech Inc | Efficacy Supplement with Clinical Data to Support |
| Sylatron | peginterferon alfa-2b | Vial | Schering | Labeling Revision |
| Transderm Scop | scopolamine | Film, Extended Release; Transdermal | Novartis | Manufacturing Change or Addition |
| Xofigo | radium ra 223 dichloride | Injectable; Injection | Bayer Pharms | Approval |
| Zolmitriptan | zolmitriptan | Tablet, Orally Disintegrating; Oral | Zydus Pharms Usa Inc | Approval |
May 14, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Climara | estradiol | Film, Extended Release; Transdermal | Bayer Hlthcare | Manufacturing Change or Addition |
| Lupron Depot-Ped | leuprolide acetate | Injectable; Injection | Abbott Endocrine | Labeling Revision |
| Megace Es | megestrol acetate | Suspension; Oral | Par Pharm | Labeling Revision |
| Retin-A | tretinoin | Gel; Topical | Valeant Intl | Manufacturing Change or Addition |
| Ridaura | auranofin | Capsule; Oral | Prometheus Labs | Manufacturing Change or Addition |
| Tarceva | erlotinib hydrochloride | Tablet; Oral | Osi Pharms | New or Modified Indication |
| Zolmitriptan | zolmitriptan | Tablet; Oral | Glenmark Generics | Approval |
| Zolmitriptan | zolmitriptan | Tablet; Oral | Apotex Inc | Approval |
| Zolmitriptan | zolmitriptan | Tablet, Orally Disintegrating; Oral | Apotex Inc | Approval |
| Zolmitriptan | zolmitriptan | Tablet, Orally Disintegrating; Oral | Glenmark Generics | Approval |
| Zolmitriptan | zolmitriptan | Tablet; Oral | Mylan Pharms Inc | Approval |
May 13, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Entacapone | entacapone | Tablet; Oral | Mylan Pharms Inc | Approval |
| Humira | adalimumab | Syringe | Abbott | Labeling Revision |
| Humira | adalimumab | Vial | Abbott | Labeling Revision |
| Minocycline Hydrochloride | minocycline hydrochloride | Capsule; Oral | Caraco | Approval |
| Opana ER | oxymorphone hydrochloride | Tablet, Extended Release; Oral | Endo Pharms | Manufacturing Change or Addition |
| Prepopik | citric acid; magnesium oxide; sodium picosulfate | For Solution; Oral | Ferring Pharms AS | Manufacturing Change or Addition |
| Ultra-Technekow FM | technetium tc-99m sodium pertechnetate generator | Solution; Injection, Oral | Mallinckrodt | Manufacturing Change or Addition |
May 11, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Tasmar | tolcapone | Tablet; Oral | Valeant Pharms Llc | Labeling Revision |
May 10, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Besivance | besifloxacin hydrochloride | Suspension/Drops; Ophthalmic | Bausch and Lomb | Manufacturing Change or Addition |
| Breo Ellipta | fluticasone furoate; vilanterol trifenatate | Powder; Inhalation | Glaxo Grp Ltd | Approval |
| Complera | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | Tablet; Oral | Gilead Sciences Inc | Manufacturing Change or Addition |
| Conray | iothalamate meglumine | Injectable; Injection | Mallinckrodt | Manufacturing Change or Addition |
| Conray 30 | iothalamate meglumine | Injectable; Injection | Mallinckrodt | Manufacturing Change or Addition |
| Conray 43 | iothalamate meglumine | Injectable; Injection | Mallinckrodt | Manufacturing Change or Addition |
| Cyklokapron | tranexamic acid | Injectable; Injection | Pharmacia and Upjohn | Labeling Revision |
| Cysto-Conray | iothalamate meglumine | Solution; Intravesical, Ureteral | Mallinckrodt | Manufacturing Change or Addition |
| Cysto-Conray Ii | iothalamate meglumine | Solution; Intravesical | Mallinckrodt | 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 Mix 75/25 | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 Kwikpen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 Pen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Pen | insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin 70/30 | insulin recombinant human; insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin 70/30 Pen | insulin recombinant human; insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin N | insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin R | insulin recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin R Pen | insulin recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Hydrocodone Bitartrate and Acetaminophen | acetaminophen; hydrocodone bitartrate | Solution; Oral | Pai | Approval |
| Md-76r | diatrizoate meglumine; diatrizoate sodium | Injectable; Injection | Mallinckrodt | Manufacturing Change or Addition |
| Mefoxin | cefoxitin sodium | Injectable; Injection | Mylan Institutional | Labeling Revision |
| Nymalize | nimodipine | Solution; Oral | Arbor Pharms Inc | Approval |
| Ultra-Technekow Fm | technetium tc-99m sodium pertechnetate generator | Solution; Injection, Oral | Mallinckrodt | Manufacturing Change or Addition |
May 9, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Codeine Sulfate | codeine sulfate | Solution; Oral | Roxane | Labeling Revision |
| Daytrana | methylphenidate | Film, Extended Release; Transdermal | Noven Pharms Inc | Manufacturing Change or Addition |
| Diclofenac Sodium and Misoprostol | diclofenac sodium; misoprostol | Tablet, Delayed Release; Oral | Sandoz | Approval |
| Fioricet W/ Codeine | acetaminophen; butalbital; caffeine; codeine phosphate | Capsule; Oral | Watson Labs Inc | Labeling Revision |
| Fiorinal W/Codeine | aspirin; butalbital; caffeine; codeine phosphate | Capsule; Oral | Watson Labs Inc | Labeling Revision |
| Ilaris | canakinumab | Injectable; Subcutaneous | Novartis Pharms | Efficacy Supplement with Clinical Data to Support |
| Indocin | indomethacin | Suspension; Oral | Iroko Pharms | Manufacturing Change or Addition |
| Phenergan Vc W/ Codeine | codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride | Syrup; Oral | Ani Pharms | Labeling Revision |
| Phenergan W/ Codeine | codeine phosphate; promethazine hydrochloride | Syrup; Oral | Ani Pharms | Labeling Revision |
| Rituxan | rituximab | Vial | Genentech | Labeling Revision |
| Soma Compound W/ Codeine | aspirin; carisoprodol; codeine phosphate | Tablet; Oral | Meda Pharms | Labeling Revision |
| Synalgos-Dc | aspirin; caffeine; dihydrocodeine bitartrate | Capsule; Oral | Caraco | Labeling Revision |
| Veregen | sinecatechins | Ointment; Topical | Medigene Ag | Manufacturing Change or Addition |
May 8, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Erivedge | vismodegib | Capsule; Oral | Genentech | Manufacturing Change or Addition |
| Flector | diclofenac epolamine | Patch; Topical | Inst Biochem | Manufacturing Change or Addition |
| Glycine 1.5% In Plastic Container | glycine | Solution; Irrigation | B Braun | Manufacturing Change or Addition |
| Gris-Peg | griseofulvin, ultramicrosize | Tablet; Oral | Pedinol | Manufacturing Change or Addition |
| Guanfacine Hydrochloride | guanfacine hydrochloride | Tablet, Extended Release; Oral | Twi Pharms Inc | Tentative Approval |
| Incivek | telaprevir | Tablet; Oral | Vertex Pharms | Manufacturing Change or Addition |
| Lo Loestrin Fe | ethinyl estradiol | Tablet; Oral | Warner Chilcott Llc | Manufacturing Change or Addition |
| Lo Loestrin Fe | ethinyl estradiol; norethindrone acetate | Tablet; Oral | Warner Chilcott Llc | Manufacturing Change or Addition |
| Lo Loestrin Fe | ferrous fumarate | Tablet; Oral | Warner Chilcott Llc | Manufacturing Change or Addition |
| Loprox | ciclopirox | Shampoo; Topical | Medicis | Labeling Revision |
| Physiolyte In Plastic Container | magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate | Solution; Irrigation | B Braun | Manufacturing Change or Addition |
| Qvar 40 | beclomethasone dipropionate | Aerosol, Metered; Inhalation | Teva Branded Pharm | Manufacturing Change or Addition |
| Qvar 80 | beclomethasone dipropionate | Aerosol, Metered; Inhalation | Teva Branded Pharm | Manufacturing Change or Addition |
| Sodium Chloride 0.9% In Plastic Container | sodium chloride | Solution; Irrigation | B Braun | Manufacturing Change or Addition |
| Sorbitol 3.3% In Plastic Container | sorbitol | Solution; Irrigation | B Braun | Manufacturing Change or Addition |
| Sterile Water In Plastic Container | sterile water for irrigation | Liquid; Irrigation | B Braun | Manufacturing Change or Addition |
| Triamcinolone Acetonide | triamcinolone acetonide | Lotion; Topical | Versapharm Inc | Approval |
| Wc3040 | norethindrone acetate; ethinyl estradiol; ferrous fumarate | Tablet, Chewable; Oral | Warner Chilcott Llc | Approval |
May 7, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cytoxan | cyclophosphamide | Tablet; Oral | Baxter Hlthcare | Labeling Revision |
| Cytoxan | cyclophosphamide | Injectable; Injection | Baxter Hlthcare | Labeling Revision |
| Cytoxan (Lyophilized) | cyclophosphamide | Injectable; Injection | Baxter Hlthcare | Labeling Revision |
| Dyna-Hex | chlorhexidine gluconate | Solution; Topical | Xttrium | Labeling Revision |
| Gemcitabine Hydrochloride | gemcitabine hydrochloride | Injectable; Injection | Sagent Pharms | Approval |
| Gemcitabine Hydrochloride | gemcitabine hydrochloride | Injectable; Injection | Pharmaforce | Approval |
| Gemcitabine Hydrochloride | gemcitabine hydrochloride | Injectable; Injection | Jiangsu Hansoh Pharm | Approval |
| Gemcitabine Hydrochloride | gemcitabine hydrochloride | Injectable; Injection | Dr Reddys Labs Ltd | Approval |
| Gemzar | gemcitabine hydrochloride | Injectable; Injection | Lilly | Labeling Revision |
| Lyophilized Cytoxan | cyclophosphamide | Injectable; Injection | Baxter Hlthcare | Labeling Revision |
| Thyrogen | thyrotropin alfa | Injectable; Injection | Genzyme | Manufacturing Change or Addition |
| Zoledronic Acid | zoledronic acid | Injectable; Iv (Infusion) | Pharms | Approval |
May 6, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Allopurinol | allopurinol | Tablet; Oral | Accord Hlthcare | Approval |
| Amlodipine; Valsartan; Hydrochlorothiazide | amlodipine; valsartan; hydrochlorothiazide | Tablet; Oral | Lupin Ltd | Tentative Approval |
| Avinza | morphine sulfate | Capsule, Extended Release; Oral | King Pfizer | Labeling Revision |
| Dacogen | decitabine | Injectable; Intravenous | Eisai Inc | Manufacturing Change or Addition |
| Haldol | haloperidol lactate | Injectable; Injection | Janssen Pharms | Labeling Revision |
| Haldol | haloperidol decanoate | Injectable; Injection | Janssen Pharms | Labeling Revision |
| Metadate Cd | methylphenidate hydrochloride | Capsule, Extended Release; Oral | Ucb Inc | Labeling Revision |
| Optimark | gadoversetamide | Injectable; Injection | Mallinckrodt | Manufacturing Change or Addition |
| Ritalin La | methylphenidate hydrochloride | Capsule, Extended Release; Oral | Novartis | Labeling Revision |
| Simponi | golimumab | Injectable; Injection | Centocor Ortho Biotech Inc | Labeling Revision |
| Tribenzor | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | Tablet; Oral | Daiichi Sankyo | Manufacturing Change or Addition |
| Vidaza | azacitidine | Injectable; Iv-Sc | Celgene | Manufacturing Change or Addition |
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