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 |
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Page Last Updated: 07/13/2016
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