Drugs
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New and Generic Drug Approvals
Visit Drugs@FDA to Search Drug Approval Reports by Month
We have changed the format of this page. You will now find approvals listed under the date of the action, rather than the date we added the information to the website.
October 4, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
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Diovan | valsartan | Tablet; Oral | Novartis | Labeling Revision |
Diovan Hct | hydrochlorothiazide; valsartan | Tablet; Oral | Novartis | Labeling Revision |
Edarbi | azilsartan kamedoxomil | Tablet; Oral | Takeda Pharms Usa | Labeling Revision |
Jevtana Kit | cabazitaxel | Solution; Iv (Infusion) | Sanofi Aventis Us | Labeling Revision |
Timentin | clavulanate potassium; ticarcillin disodium | Injectable; Injection | Glaxosmithkline | Labeling Revision |
Timentin In Plastic Container | clavulanate potassium; ticarcillin disodium | Injectable; Injection | Glaxosmithkline | Labeling Revision |
Tracleer | bosentan | Tablet; Oral | Actelion Pharms Ltd | Efficacy Supplement with Clinical Data to Support |
October 3, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
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Irbesartan | irbesartan | Tablet; Oral | Macleods Pharms Ltd | Approval |
Oxcarbazepine | oxcarbazepine | Suspension; Oral | Roxane | Approval |
October 2, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Cystaran | cysteamine | Solution; Ophthalmic | Sigma Tau | Approval |
Edarbi | azilsartan kamedoxomil | Tablet; Oral | Takeda Pharms Usa | Labeling Revision |
Edarbyclor | azilsartan kamedoxomil; chlorthalidone | Tablet; Oral | Takeda Pharms Usa | Labeling Revision |
Imitrex | sumatriptan succinate | Injectable; Subcutaneous | Glaxosmithkline | Labeling Revision |
Imitrex Statdose | sumatriptan succinate | Injectable; Subcutaneous | Glaxosmithkline | Labeling Revision |
Zortress | everolimus | Tablet; Oral | Novartis | Labeling Revision |
Zylet | loteprednol etabonate; tobramycin | Suspension/Drops; Ophthalmic | Bausch and Lomb | Labeling Revision |
October 1, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Albuterol Sulfate and Ipratropium Bromide | albuterol sulfate; ipratropium bromide | Solution; Inhalation | Ritedose Corp | Approval |
Fluoxetine Hydrochloride | fluoxetine hydrochloride | Capsule; Oral | Heritage Pharms Inc | Approval |
September 28, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
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Amturnide | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | Tablet; Oral | Novartis | Labeling Revision |
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | cetirizine hydrochloride; pseudoephedrine hydrochloride | Tablet, Extended Release; Oral | Sun Pharm Inds Ltd | Approval |
Colistimethate Sodium | colistimethate sodium | Injectable; Injection | Emcure Pharms Ltd | Approval |
Desoximetasone | desoximetasone | Ointment; Topical | Fougera Pharms | Approval |
Dexilant | dexlansoprazole | Capsule, Delayed Release; Oral | Takeda Pharms | Labeling Revision |
Diltiazem Hydrochloride | diltiazem hydrochloride | Capsule, Extended Release; Oral | Actavis Elizabeth | Approval |
Exforge | amlodipine besylate; valsartan | Tablet; Oral | Novartis | Labeling Revision |
Exforge HCT | amlodipine besylate; hydrochlorothiazide; valsartan | Tablet; Oral | Novartis | Labeling Revision |
Hydrochlorothiazide; Irbesartan | hydrochlorothiazide; irbesartan | Tablet; Oral | Cipla Limited | Tentative Approval |
Indomethacin | indomethacin | Capsule, Extended Release; Oral | Hetero Labs Ltd Iii | Approval |
Lotemax | loteprednol etabonate | Gel; Ophthalmic | Bausch and Lomb | Approval |
Nexium | esomeprazole magnesium | Capsule, Delayed Rel Pellets; Oral | Astrazeneca | Labeling Revision |
Nexium | esomeprazole magnesium | For Suspension, Delayed Release; Oral | Astrazeneca | Labeling Revision |
Nexium | esomeprazole magnesium | For Suspension, Delayed Release; Oral | Astrazeneca | Labeling Revision |
Nexium IV | esomeprazole sodium | Injectable; Intravenous | Astrazeneca | Labeling Revision |
Pantoprazole Sodium | pantoprazole sodium | Tablet, Delayed Release; Oral | Aurobindo Pharma Ltd | Approval |
Phentermine Hydrochloride | phentermine hydrochloride | Capsule; Oral | Elite Labs | Approval |
Prevacid | lansoprazole | Capsule, Delayed Rel Pellets; Oral | Takeda Pharms USA | Labeling Revision |
Prevacid | lansoprazole | Tablet, Delayed Release, Orally Disintegrating; Oral | Takeda Pharms USA | Labeling Revision |
Prilosec | omeprazole | Capsule, Delayed Rel Pellets; Oral | Astrazeneca | Labeling Revision |
Prilosec | omeprazole magnesium | For Suspension, Delayed Release; Oral | Astrazeneca | Labeling Revision |
Progesterone | progesterone | Capsule; Oral | Sofgen Pharms | Approval |
Protonix Iv | pantoprazole sodium | Injectable; Iv (Infusion) | Wyeth Pharms Inc | Labeling Revision |
Quinine Sulfate | quinine sulfate | Capsule; Oral | Teva Pharms | Approval |
Tacrolimus | tacrolimus | Capsule; Oral | Panacea Biotec Ltd | Approval |
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 |
Tradjenta | linagliptin | Tablet; Oral | Boehringer Ingelheim | Efficacy Supplement with Clinical Data to Support |
September 27, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Digoxin | digoxin | Elixir; Oral | Roxane | Labeling Revision |
Foradil | formoterol fumarate | Powder; Inhalation | Novartis | Labeling Revision |
Irbesartan | irbesartan | Tablet; Oral | Sandoz | Approval |
Irbesartan | irbesartan | Tablet; Oral | Zydus Pharms USA Inc | Approval |
Irbesartan | irbesartan | Tablet; Oral | Mylan Pharms Inc | Approval |
Irbesartan | irbesartan | Tablet; Oral | Prinston Inc | Approval |
Irbesartan | irbesartan | Tablet; Oral | Aurobindo Pharma Ltd | Approval |
Irbesartan | irbesartan | Tablet; Oral | Dr Reddys Labs Ltd | Approval |
Irbesartan and Hydrochlorothiazide | hydrochlorothiazide; irbesartan | Tablet; Oral | Sandoz | Approval |
Irbesartan and Hydrochlorothiazide | hydrochlorothiazide; irbesartan | Tablet; Oral | Mylan Pharms Inc | Approval |
Irbesartan and Hydrochlorothiazide | hydrochlorothiazide; irbesartan | Tablet; Oral | Macleods Pharms Ltd | Approval |
Irbesartan and Hydrochlorothiazide | hydrochlorothiazide; irbesartan | Tablet; Oral | Dr Reddys Labs Ltd | Approval |
Irbesartan; Hydrochlorothiazide | irbesartan: hydrochlorothiazide | Tablet; Oral | Macleods Pharms Ltd | Approval |
Modafinil | modafinil | Tablet; Oral | Aurobindo Pharma Ltd | Approval |
Quillivant Xr | methylphenidate hydrochloride | Suspension; Oral | Nextwave Pharms Inc | Approval |
Singulair | montelukast sodium | Tablet; Oral | Merck | Labeling Revision |
Singulair | montelukast sodium | Tablet, Chewable; Oral | Merck | Labeling Revision |
Singulair | montelukast sodium | Granule; Oral | Merck | Labeling Revision |
Sodium Chloride 0.9% In Plastic Container | sodium chloride | Injectable; Injection | Medefil | Labeling Revision |
Sorilux | calcipotriene | Aerosol, Foam; Topical | Stiefel Labs Inc | Labeling Revision |
Stivarga | regorafenib | Tablet; Oral | Bayer Healthcare Pharms | Approval |
September 26, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Arcapta Neohaler | indacaterol maleate | Powder; Inhalation | Novartis | Labeling Revision |
Modafinil | modafinil | Tablet; Oral | Orchid Hlthcare | Approval |
Modafinil | modafinil | Tablet; Oral | Hikma Pharms | Approval |
Pioglitazone Hydrochloride | pioglitazone hydrochloride | Tablet; Oral | Macleods Pharms Ltd | Tentative Approval |
Pioglitazone Hydrochloride; Metformin Hydrochloride | pioglitazone hydrochloride; metformin hydrochloride | Tablet; Oral | Aurobindo Pharma Ltd | Tentative Approval |
Pregabalin | pregabalin | Capsule; Oral | Wockhardt Usa | Tentative Approval |
Sildenafil Citrate | sildenafil citrate | Tablet; Oral | Dr Reddys Labs Ltd | Tentative Approval |
Vinorelbine Tartrate | vinorelbine tartrate | Injectable; Injection | Jiangsu Hansoh Pharma | Approval |
September 25, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Amlodipine,Valsartan and Hydrochlorothiazide | amlodipine; hydrochlorothiazide; valsartan | Tablet; Oral | Teva Pharms | Approval |
Cellcept | mycophenolate mofetil | Capsule; Oral | Roche Palo | Labeling Revision |
Cellcept | mycophenolate mofetil | Tablet; Oral | Roche Palo | Labeling Revision |
Cellcept | mycophenolate mofetil hydrochloride | Injectable; Injection | Roche Palo | Labeling Revision |
Cellcept | mycophenolate mofetil | Suspension; Oral | Roche Palo | Labeling Revision |
Entereg | alvimopan | Capsule; Oral | Cubist Pharms | Labeling Revision |
Ethosuximide | ethosuximide | Capsule; Oral | Zydus Pharms Usa Inc | Approval |
Jentadueto | linagliptin; metformin hydrochloride | Tablet; Oral | Boehringer Ingelheim | Labeling Revision |
Myfortic | mycophenolic acid | Tablet, Delayed Release; Oral | Novartis | Labeling Revision |
Perforomist | formoterol fumarate | Solution; Inhalation | Dey Pharma | Labeling Revision |
Tolterodine Tartrate | tolterodine tartrate | Tablet; Oral | Apotex Corp | Approval |
September 24, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Aprepitant | aprepitant | Capsule; Oral | Sandoz | Approval |
Cayston | aztreonam | For Solution; Inhalation | Gilead | Labeling Revision |
Cilostazol | cilostazol | Tablet; Oral | Biokey | Approval |
Cilostazol | cilostazol | Tablet; Oral | Biokey | Approval |
Hydrochlorothiazide | hydrochlorothiazide | Tablet; Oral | Accord Hlthcare | Approval |
Losartan Potassium | losartan potassium | Tablet; Oral | Micro Labs Ltd India | Approval |
Methscopolamine Bromide | methscopolamine bromide | Tablet; Oral | Bayshore Pharms Llc | Approval |
September 21, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Accupril | quinapril hydrochloride | Tablet; Oral | Pfizer Pharms | Labeling Revision |
Accuretic | hydrochlorothiazide; quinapril hydrochloride | Tablet; Oral | Pfizer Pharms | Labeling Revision |
Celecoxib | celecoxib | Capsule; Oral | Watson Labs Inc | Tentative Approval |
Eylea | aflibercept | Injectable; Injection | Regeneron Pharmaceuticals | Efficacy Supplement with Clinical Data to Support |
Lamivudine; Nevirapine; Zidovudine | lamivudine; nevirapine; zidovudine | Tablet, For Suspension; Oral | Strides Arcolab Ltd | Tentative Approval |
Lotensin | benazepril hydrochloride | Tablet; Oral | Novartis | Labeling Revision |
Lotensin Hct | benazepril hydrochloride; hydrochlorothiazide | Tablet; Oral | Novartis | Labeling Revision |
Montelukast Sodium | montelukast sodium | Tablet; Oral | Accord Hlthcare | Approval |
Phentermine Hydrochloride | phentermine hydrochloride | Tablet; Oral | Mirror Pharms | Approval |
Valsartan and Hydrochlorothiazide | hydrochlorothiazide; valsartan | Tablet; Oral | Mylan Pharms Inc | Approval |
Venofer | iron sucrose | Injectable; Intravenous | Luitpold | Efficacy Supplement with Clinical Data to Support |
September 20, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Androgel | testosterone | Gel, Metered; Transdermal | Abbvie | Labeling Revision |
Androgel | testosterone | Gel; Transdermal | Abbvie | Labeling Revision |
Carbamazepine | carbamazepine | Capsule, Extended Release; Oral | Teva Pharms | Approval |
Carbamazepine | carbamazepine | Capsule, Extended Release; Oral | Teva Pharms Usa | Tentative Approval |
Glycopyrrolate | glycopyrrolate | Tablet; Oral | Excellium | Approval |
Micardis | telmisartan | Tablet; Oral | Boehringer Ingelheim | Labeling Revision |
Nicoderm Cq | nicotine | Film, Extended Release; Transdermal | Sanofi Aventis Us | Labeling Revision |
Pramipexole Dihydrochloride | pramipexole dihydrochloride | Tablet; Oral | Macleods Pharms Ltd | Approval |
Prolia | denosumab | Injectable; Subcutaneous | Amgen | Efficacy Supplement with Clinical Data to Support |
Xgeva | denosumab | Injectable; Subcutaneous | Amgen | Efficacy Supplement with Clinical Data to Support |
September 19, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Doxil | doxorubicin hydrochloride | Injectable, Liposomal; Injection | Janssen R and D | Labeling Revision |
Prevacid 24 Hr | lansoprazole | Capsule, Delayed Rel Pellets; Oral | Novartis | Labeling Revision |
September 18, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Benicar Hct | hydrochlorothiazide; olmesartan medoxomil | Tablet; Oral | Daiichi Sankyo | Labeling Revision |
Besivance | besifloxacin hydrochloride | Suspension/Drops; Ophthalmic | Bausch and Lomb | Efficacy Supplement with Clinical Data to Support |
Juvisync | simvastatin; sitagliptin phosphate | Tablet; Oral | Merck Sharp Dohme | Efficacy Supplement with Clinical Data to Support |
Juvisync | simvastatin; sitagliptin phosphate | Tablet; Oral | Merck Sharp Dohme | Labeling Revision |
Losartan Potassium | losartan potassium | Tablet; Oral | Cadista Pharms | Approval |
Losartan Potassium and Hydrochlorothiazide | hydrochlorothiazide; losartan potassium | Tablet; Oral | Cadista Pharms | Approval |
Nicorette | nicotine polacrilex | Troche/Lozenge; Oral | Glaxosmithkline Cons | Labeling Revision |
Rizatriptan Benzoate | rizatriptan benzoate | Tablet; Oral | Glenmark Generics | Tentative Approval |
Testosterone Enanthate | testosterone enanthate | Injectable; Injection | Hikma Farmaceutica | Approval |
Zegerid Otc | omeprazole; sodium bicarbonate | Capsule; Oral | Msd Consumer | Labeling Revision |
September 17, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Aldactone | spironolactone | Tablet; Oral | Gd Searle Llc | Approval |
Combivent | albuterol sulfate; ipratropium bromide | Aerosol, Metered; Inhalation | Boehringer Ingelheim | Approval |
Fluocinonide | fluocinonide | Cream; Topical | Fougera Pharms | Tentative Approval |
Glyset | miglitol | Tablet; Oral | Pharmacia and Upjohn | Labeling Revision |
Montelukast Sodium | montelukast sodium | Granule; Oral | Dr Reddys Labs Ltd | Approval |
Oxcarbazepine | oxcarbazepine | Suspension; Oral | Amneal Pharms | Approval |
Zytiga | abiraterone acetate | Tablet; Oral | Janssen Biotech | Labeling Revision |
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