New and Generic Drug Approvals
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Amlodipine Besylate | amlodipine besylate | Tablet;Oral | Polygen Pharms | Approval |
Asmanex Hfa | mometasone furoate | Aerosol, Metered;Inhalation | Merck Sharp Dohme | Efficacy Supplement with Clinical Data to Support |
Cialis | tadalafil | Tablet;Oral | Lilly | Manufacturing Change or Addition |
Cymbalta | duloxetine hydrochloride | Capsule, Delayed Rel Pellets;Oral | Lilly | Manufacturing Change or Addition |
Dulera | formoterol fumarate; mometasone furoate | Aerosol, Metered;Inhalation | Merck Sharp Dohme | Efficacy Supplement with Clinical Data to Support |
Effient | prasugrel hydrochloride | Tablet;Oral | Eli Lilly and Co | Efficacy Supplement with Clinical Data to Support |
Faslodex | fulvestrant | Injectable;Intramuscular | Astrazeneca | Labeling Revision |
Tarka | trandolapril; verapamil hydrochloride | Tablet, Extended Release;Oral | Abbvie | Labeling Revision |
July 11, 2016
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Alinia | nitazoxanide | Tablet;Oral | Romark | Labeling Revision |
Alinia | nitazoxanide | For Suspension;Oral | Romark | Labeling Revision |
Brovana | arformoterol tartrate | Solution;Inhalation | Sunovion | Manufacturing Change or Addition |
Furadantin | nitrofurantoin | Suspension;Oral | Shionogi Inc | Manufacturing Change or Addition |
Gatifloxacin | gatifloxacin | Solution/Drops;Ophthalmic | Alcon Res Ltd | Approval |
Juxtapid | lomitapide mesylate | Capsule;Oral | Aegerion | Manufacturing Change or Addition |
Metformin Hydrochloride | metformin hydrochloride | Tablet;Oral | Cspc Ouyi Pharm Co | Approval |
Vilazodone Hydrochloride | vilazodone hydrochloride | Tablet;Oral | Teva Pharms Usa | Tentative Approval |
Xiidra | lifitegrast | Solution/Drops; Ophthalmic | Shire Dev Llc | Approval |
July 8, 2016
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Absorica | isotretinoin | Capsule;Oral | Ranbaxy | Supplement |
Benicar | olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Manufacturing Change or Addition |
Dexilant | dexlansoprazole | Capsule, Delayed Release;Oral | Takeda Pharms Usa | Efficacy Supplement with Clinical Data to Support |
Dexilant Solutab | dexlansoprazole | Tablet, Orally Disintegrating, Delayed Release;Oral | Takeda Pharms Usa | Labeling Revision |
Differin | adapalene | Gel;Topical | Galderma Labs Lp | Efficacy Supplement with Clinical Data to Support |
Duexis | famotidine; ibuprofen | Tablet;Oral | Horizon Pharma | Manufacturing Change or Addition |
Femcon Fe | ethinyl estradiol; norethindrone | Tablet, Chewable;Oral | Apil | Manufacturing Change or Addition |
Glyxambi | empagliflozin; linagliptin | Tablet;Oral | Boehringer Ingelheim | Labeling Revision |
Hicon | sodium iodide i-131 | Solution;Oral | Jubilant Draximage | Labeling Revision |
Humulin R | insulin human | Solution;Subcutaneous | Lilly | Labeling Revision |
Humulin R | insulin recombinant human | Injectable;Injection | Lilly | Labeling Revision |
Humulin R Kwikpen | insulin human | Solution;Subcutaneous | Lilly | Labeling Revision |
Humulin R Pen | insulin recombinant human | Injectable;Injection | Lilly | Labeling Revision |
Idkit:hp | citric acid; urea c-13 | For Solution, Tablet, For Solution;Oral | Exalenz Bioscience | Manufacturing Change or Addition |
Jardiance | empagliflozin | Tablet;Oral | Boehringer Ingelheim | Labeling Revision |
Lamprene | clofazimine | Capsule;Oral | Novartis | Labeling Revision |
Latuda | lurasidone hydrochloride | Tablet;Oral | Sunovion Pharms Inc | Manufacturing Change or Addition |
Lyrica | pregabalin | Capsule;Oral | Pf Prism Cv | Manufacturing Change or Addition |
Menopur | menotropins (fsh;lh) | Injectable;Subcutaneous | Ferring | Manufacturing Change or Addition |
Omidria | ketorolac tromethamine; phenylephrine hydrochloride | Solution;Irrigation | Omeros | Manufacturing Change or Addition |
Pentetate Calcium Trisodium | pentetate calcium trisodium | Solution;Inhalation, Intravenous | Hameln Pharma Plus | Manufacturing Change or Addition |
Repatha | evolocumab | Injectable;Injection | Amgen Inc | Efficacy Supplement with Clinical Data to Support |
Repatha | evolocumab | Injectable;Injection | Amgen Inc | Labeling Revision |
Sodium Iodide I 131 | sodium iodide i-131 | Capsule;Oral | Jubilant Draximage | Labeling Revision |
Synjardy | empagliflozin; metformin hydrochloride | Tablet;Oral | Boehringer Ingelheim | Efficacy Supplement with Clinical Data to Support |
Synjardy | empagliflozin; metformin hydrochloride | Tablet;Oral | Boehringer Ingelheim | Labeling Revision |
Tegretol | carbamazepine | Suspension;Oral | Novartis | Manufacturing Change or Addition |
Tresiba | insulin degludec | Solution;Subcutaneous | Novo Nordisk Inc | Manufacturing Change or Addition |
Veregen | sinecatechins | Ointment;Topical | Medigene Ag | Manufacturing Change or Addition |
July 7, 2016
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Bunavail | buprenorphine hydrochloride; naloxone hydrochloride | Film;Buccal | Biodelivery Sci Intl | Supplement |
Cerezyme | imiglucerase | Injectable;Injection | Genzyme | Manufacturing Change or Addition |
Hydromorphone Hydrochloride | hydromorphone hydrochloride | Tablet, Extended Release;Oral | Osmotica | Approval |
Intuniv | guanfacine hydrochloride | Tablet, Extended Release;Oral | Shire | Labeling Revision |
Mili | ethinyl estradiol; norgestimate | Tablet;Oral-28 | Aurobindo Pharma Ltd | Approval |
Suboxone | buprenorphine hydrochloride; naloxone hydrochloride | Tablet;Sublingual | Indivior Inc | Supplement |
Suboxone | buprenorphine hydrochloride; naloxone hydrochloride | Film;Buccal, Sublingual | Indivior Inc | Supplement |
Subutex | buprenorphine hydrochloride | Tablet;Sublingual | Indivior Inc | Supplement |
Triamcinolone Acetonide | triamcinolone acetonide | Lotion;Topical | Teligent Pharma Inc | Approval |
Triamcinolone Acetonide | triamcinolone acetonide | Lotion;Topical | Teligent Pharma Inc | Approval |
Zubsolv | buprenorphine hydrochloride; naloxone hydrochloride | Tablet;Sublingual | Orexo Ab | Supplement |
July 6, 2016
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Cubicin | daptomycin | Powder;Intravenous | Cubist | Labeling Revision |
Cubicin | daptomycin | Powder;Iv (Infusion) | Cubist | Labeling Revision |
Eltrombopag | eltrombopag | Tablet;Oral | Hetero Labs Ltd V | Tentative Approval |
Granisetron Hydrochloride | granisetron hydrochloride | Injectable;Injection | Aurobindo Pharma Ltd | Approval |
Habitrol | nicotine | Film, Extended Release; Transdermal | Dr Reddys Labs Inc | Labeling Revision |
Habitrol | nicotine | Film, Extended Release;Transdermal | Dr Reddys Labs Inc | Labeling Revision |
Nateglinide | nateglinide | Tablet;Oral | Zydus Pharms Usa Inc | Approval |
Tri-Mili | ethinyl estradiol; norgestimate | Tablet;Oral-28 | Aurobindo Pharma Ltd | Approval |
Xolair | omalizumab | Vial | Genentech | Efficacy Supplement with Clinical Data to Support |
..........................................................................................
Page Last Updated: 07/13/2016
/

..............................................................................................
/
No comments:
Post a Comment