FDA Generic and New Drug Approvals-7 November 2015

FDA’s Recent Approvals

New Drug and Generic Approvals

Date:             November 7, 2015

The following provides FDA links (downloadable below in PDF) to approval information for recent generic and new drug applications.

November 5, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Advil ibuprofen sodium Tablet;Oral Pfizer Cons Hlthcare Manufacturing Change or Addition
Carbaglu carglumic acid Tablet;Oral Orphan Europe Manufacturing Change or Addition
Claritin loratadine Syrup;Oral Bayer Healthcare Llc Labeling Revision
Claritin Hives Relief loratadine Syrup;Oral Bayer Healthcare Llc Labeling Revision
Ddavp desmopressin acetate Solution;Nasal Ferring Pharms Inc Labeling Revision
Ddavp desmopressin acetate Spray, Metered;Nasal Ferring Pharms Inc Labeling Revision
Ddavp desmopressin acetate Injectable;Injection Ferring Pharms Inc Labeling Revision
Ddavp (Needs No Refrigeration) desmopressin acetate Spray, Metered;Nasal Ferring Pharms Inc Labeling Revision
Genvoya elvitegravir;cobicistat;emtricitabine;tenofovir alagenamide Tablet;Combination, Fixed Dose Gilead Sciences Inc Approval
Hydase hyaluronidase Injectable;Injection Akorn Inc Labeling Revision
Iopidine apraclonidine hydrochloride Solution/Drops;Ophthalmic Alcon Manufacturing Change or Addition
Jublia efinaconazole Solution;Topical Dow Pharm Manufacturing Change or Addition
Lescol fluvastatin sodium Capsule;Oral Novartis Manufacturing Change or Addition
Lescol Xl fluvastatin sodium Tablet, Extended Release;Oral Novartis Manufacturing Change or Addition
Megace Es megestrol acetate Suspension;Oral Par Pharm Manufacturing Change or Addition
Rapamune sirolimus Solution;Oral Pf Prism Cv Labeling Revision
Rapamune sirolimus Tablet;Oral Pf Prism Cv Labeling Revision
Simbrinza brimonidine tartrate; brinzolamide Suspension/Drops;Ophthalmic Alcon Res Ltd Labeling Revision
Tivicay dolutegravir sodium Tablet;Oral Viiv Hlthcare Manufacturing Change or Addition
Treanda bendamustine hydrochloride Powder;Iv (Infusion) Cephalon Labeling Revision
Treanda bendamustine hydrochloride Solution;Iv (Infusion) Cephalon Labeling Revision
Zortress everolimus Tablet;Oral Novartis Labeling Revision

November 4, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Efudex fluorouracil Cream;Topical Valeant Pharm Intl Manufacturing Change or Addition
Efudex fluorouracil Solution;Topical Valeant Pharm Intl Manufacturing Change or Addition
Felbamate felbamate Tablet;Oral Corepharma Approval
Gabitril tiagabine hydrochloride Tablet;Oral Cephalon Labeling Revision
Impavido miltefosine Capsule;Oral Knight Theraps Manufacturing Change or Addition
Ketek telithromycin Tablet;Oral Sanofi Aventis Us Labeling Revision
Nucala mepolizumab Injectable;Subcutaneous Lyophilized Power Glaxosmithkline Llc Approval
Palonosetron Hydrochloride palonosetron hydrochloride Injectable;Injection Aurobindo Pharma Ltd Tentative Approval

November 3, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Glucagon glucagon hydrochloride Powder;Intramuscular, Intravenous Fresenius Kabi Usa Manufacturing Change or Addition
Sabril vigabatrin For Solution;Oral Lundbeck Llc Labeling Revision
Sevoflurane sevoflurane Liquid;Inhalation Shanghai Hengrui Approval

November 2, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Abraxane paclitaxel For Suspension;Iv (Infusion) Abraxis Bioscience Manufacturing Change or Addition
Ammonia N 13 ammonia n-13 Injectable;Intravenous Petnet Approval
Clotrimazole and Betamethasone Dipropionate betamethasone dipropionate; clotrimazole Cream;Topical Glenmark Pharms Ltd Approval
Myrbetriq mirabegron Tablet, Extended Release;Oral Apgdi Labeling Revision
Sandimmune cyclosporine Injectable;Injection Novartis Manufacturing Change or Addition
Somatuline Depot lanreotide acetate Solution;Subcutaneous Ipsen Pharma Manufacturing Change or Addition
Stendra avanafil Tablet;Oral Vivus Manufacturing Change or Addition
Telmisartan and Hydrochlorothiazide hydrochlorothiazide; telmisartan Tablet;Oral Macleods Pharms Ltd Approval

October 30, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Actigall ursodiol Capsule;Oral Actavis Labs Ut Inc Manufacturing Change or Addition
Atropine Sulfate Ansyr Plastic Syringe atropine sulfate Injectable;Intramuscular, Intravenous, Subcutaneous Hospira Labeling Revision
Butalbital and Acetaminophen acetaminophen; butalbital Tablet;Oral Tedor Pharma Inc Approval
Butalbital, Aspirin, Caffeine and Codeine Phosphate aspirin; butalbital; caffeine; codeine phosphate Capsule;Oral Coastal Pharms Approval
Cerezyme imiglucerase Injectable;Injection Genzyme Manufacturing Change or Addition
Condylox podofilox Solution;Topical Actavis Labs Ut Inc Manufacturing Change or Addition
Donepezil Hydrochloride donepezil hydrochloride Tablet;Oral Lupin Ltd Approval
Fludeoxyglucose F18 fludeoxyglucose f-18 Injectable;Intravenous 3d Imaging Drug Approval
Heparin Sodium heparin sodium Injectable;Injection Eurohlth Intl Sarl Manufacturing Change or Addition
Hepatolite technetium tc-99m disofenin kit Injectable;Injection Pharmalucence Manufacturing Change or Addition
Itraconazole itraconazole Solution;Oral Amneal Pharms Approval
Keflex cephalexin Capsule;Oral Shionogi Inc Labeling Revision
Lisdexamfetamine Dimesylate lisdexamfetamine dimesylate Capsule;Oral Actavis Elizabeth Tentative Approval
Morphine Sulfate morphine sulfate Solution;Oral Vintage Pharms Llc Approval
Prandin repaglinide Tablet;Oral Novo Nordisk Inc Manufacturing Change or Addition
Renacidin citric acid; gluconolactone; magnesium carbonate Solution;Irrigation United Guardian Labeling Revision
Savaysa edoxaban tosylate Tablet;Oral Daiichi Sankyo Manufacturing Change or Addition
Sitagliptin Phosphate; Metformin Hydrochloride sitagliptin phosphate; metformin hydrochloride Tablet;Oral Watson Labs Inc Tentative Approval
Tegretol carbamazepine Tablet;Oral Novartis Manufacturing Change or Addition
Telmisartan telmisartan Tablet;Oral Inventia Hlthcare Approval

October 29, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Choline C-11 choline c-11 Injectable;Intravenous Univ Tx Md Anderson Approval
Miralax polyethylene glycol 3350 For Solution;Oral Bayer Healthcare Llc Labeling Revision
Modicon 28 ethinyl estradiol; norethindrone Tablet;Oral-28 Janssen Pharms Labeling Revision
Omeprazole; Sodium Bicarbonate omeprazole; sodium bicarbonate Capsule;Oral Ajanta Pharma Ltd Tentative Approval
Ortho-Novum 1/35-28 ethinyl estradiol; norethindrone Tablet;Oral-28 Janssen Pharms Labeling Revision
Ortho-Novum 7/7/7-21 ethinyl estradiol; norethindrone Tablet;Oral-21 Janssen Pharms Labeling Revision
Ortho-Novum 7/7/7-28 ethinyl estradiol; norethindrone Tablet;Oral-28 Janssen Pharms Labeling Revision
Seebri Neohaler glycopyrrolate Powder;Inhalation Novartis Pharms Corp Approval
Taclonex betamethasone dipropionate; calcipotriene hydrate Suspension;Topical Leo Pharma As Manufacturing Change or Addition
Utibron Neohaler indacaterol;glycopyrrolate Powder;Inhalation Novartis Pharms Corp Approval
Valchlor mechlorethamine hydrochloride Gel;Topical Actelion Pharms Ltd Labeling Revision
Vazculep phenylephrine hydrochloride Solution;Iv (Infusion) Eclat Pharms Llc Manufacturing Change or Addition
  • Source: FDA

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Last Updated: 2015-11-07

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