Drugs

New and Generic Drug Approvals

 

September 27, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Avelox moxifloxacin hydrochloride Tablet;Oral Bayer Hlthcare Efficacy Supplement with Clinical Data to Support
Avelox moxifloxacin hydrochloride Tablet;Oral Bayer Hlthcare Labeling Revision
Avelox In Sodium Chloride 0.8% In Plastic Container moxifloxacin hydrochloride Solution;Iv (Infusion) Bayer Hlthcare Efficacy Supplement with Clinical Data to Support
Avelox In Sodium Chloride 0.8% In Plastic Container moxifloxacin hydrochloride Solution;Iv (Infusion) Bayer Hlthcare Labeling Revision
Clinimix 2.75/10 Sulfite Free In Dextrose 10% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix 2.75/25 Sulfite Free In Dextrose 25% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix 2.75/5 Sulfite Free In Dextrose 5% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix 4.25/10 Sulfite Free In Dextrose 10% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix 4.25/20 Sulfite Free In Dextrose 20% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix 4.25/25 Sulfite Free In Dextrose 25% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix 4.25/5 Sulfite Free In Dextrose 5% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix 5/10 Sulfite Free In Dextrose 10% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix 5/15 Sulfite Free In Dextrose 15% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix 5/20 Sulfite Free In Dextrose 20% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix 5/25 Sulfite Free In Dextrose 25% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix 5/35 Sulfite Free In Dextrose 35% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix E 2.75/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix E 2.75/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix E 4.25/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix E 4.25/20 Sulfite Free W/ Elect In Dextrose 20% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix E 4.25/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix E 4.25/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix E 5/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix E 5/15 Sulfite Free W/ Elect In Dextrose 15% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix E 5/20 Sulfite Free W/ Elect In 20% Dextrose W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix E 5/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Clinimix E 5/35 Sulfite Free W/ Elect In Dextrose 35% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
E-Z-Hd barium sulfate For Suspension;Oral Bracco Manufacturing Change or Addition
Gleevec imatinib mesylate Tablet;Oral Novartis Labeling Revision
Parlodel bromocriptine mesylate Capsule;Oral Us Pharms Holdings I Manufacturing Change or Addition
Parlodel bromocriptine mesylate Tablet;Oral Us Pharms Holdings I Manufacturing Change or Addition
Proair Respiclick albuterol sulfate Powder, Metered;Inhalation Teva Branded Pharm Manufacturing Change or Addition
Proventil-Hfa albuterol sulfate Aerosol, Metered;Inhalation 3m Manufacturing Change or Addition
Rilutek riluzole Tablet;Oral Covis Pharma Sarl Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container sodium chloride Injectable;Injection Hospira Labeling Revision
Sodium Chloride 0.9% In Plastic Container sodium chloride Injectable;Injection Hospira Labeling Revision
Sprycel dasatinib Tablet;Oral Bristol Myers Squibb Labeling Revision
Tasigna nilotinib hydrochloride monohydrate Capsule;Oral Novartis Labeling Revision

 

September 26, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Abacavir Sulfate abacavir sulfate Solution;Oral Hetero Labs Ltd Iii Approval
Itraconazole itraconazole Capsule;Oral Amneal Pharms Approval
Zoledronic Acid zoledronic acid Injectable;Iv (Infusion) Aurobindo Pharma Ltd Approval

 

September 23, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Actemra tocilizumab Injectable; Injection Genentech Efficacy Supplement with Clinical Data to Support
Actemra tocilizumab Injectable;Intravenous, Subcutaneous Genentech Efficacy Supplement with Clinical Data to Support
Acuvail ketorolac tromethamine Solution/Drops;Ophthalmic Allergan Manufacturing Change or Addition
Akynzeo netupitant; palonosetron hydrochloride Capsule;Oral Helsinn Hlthcare Manufacturing Change or Addition
Ambisome amphotericin b Injectable, Liposomal;Injection Astellas Manufacturing Change or Addition
Amjevita adalimumab-atto Injectable;Injection Amgen Inc Approval
Ayuna ethinyl estradiol; levonorgestrel Tablet;Oral-28 Aurobindo Pharma Ltd Approval
Basaglar insulin glargine Solution;Subcutaneous Eli Lilly and Co Manufacturing Change or Addition
Brilinta ticagrelor Tablet;Oral Astrazeneca Lp Labeling Revision
Butalbital, Aspirin and Caffeine aspirin; butalbital; caffeine Tablet;Oral Pharmaceutics Intl Approval
Equetro carbamazepine Capsule, Extended Release;Oral Validus Pharms Inc Efficacy Supplement with Clinical Data to Support
Esmolol esmolol hydrochloride Injectable;Injection Gland Pharma Ltd Tentative Approval
Ilaris canakinumab Injectable; Subcutaneous Novartis Pharms Efficacy Supplement with Clinical Data to Support
Incassia norethindrone Tablet;Oral-28 Aurobindo Pharma Ltd Approval
Loratadine loratadine Capsule;Oral Marksans Pharma Approval
Lotensin Hct benazepril hydrochloride; hydrochlorothiazide Tablet;Oral Us Pharms Holdings I Manufacturing Change or Addition
Menopur menotropins (fsh;lh) Injectable;Subcutaneous Ferring Manufacturing Change or Addition
Nicardipine Hydrochloride nicardipine hydrochloride Injectable;Injection Exela Pharma Science Labeling Revision
Ofev nintedanib esylate Capsule;Oral Boehringer Ingelheim Manufacturing Change or Addition
Olopatadine Hydrochloride olopatadine hydrochloride Solution;Ophthalmic Akorn Inc Tentative Approval
Rexulti brexpiprazole Tablet;Oral Otsuka Pharm Co Ltd Efficacy Supplement with Clinical Data to Support
Stelara ustekinumab Injectable;Injection Janssen Biotech Approval
Varithena polidocanol Solution;Intravenous Provensis Manufacturing Change or Addition

 

September 22, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Femcon Fe ethinyl estradiol; norethindrone Tablet, Chewable;Oral Apil Labeling Revision
Furosemide furosemide Injectable;Injection Hospira Labeling Revision
Habitrol nicotine Film, Extended Release; Transdermal Dr Reddys Labs Inc Manufacturing Change or Addition
Habitrol nicotine Film, Extended Release;Transdermal Dr Reddys Labs Inc 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 Pen insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humulin R insulin human Solution;Subcutaneous Lilly Manufacturing Change or Addition
Humulin R insulin recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Humulin R Kwikpen insulin human Solution;Subcutaneous Lilly Manufacturing Change or Addition
Humulin R Pen insulin recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Jublia efinaconazole Solution;Topical Dow Pharm Labeling Revision
Methylphenidate Hydrochloride methylphenidate hydrochloride Tablet, Extended Release;Oral Actavis Labs Fl Inc Tentative Approval
Methylphenidate Hydrochloride methylphenidate hydrochloride Tablet, Extended Release;Oral Actavis Labs Fl Inc Tentative Approval
Nasacort Allergy 24 Hour triamcinolone acetonide Spray, Metered;Nasal Sanofi Aventis Us Labeling Revision
Saxenda liraglutide recombinant Solution;Subcutaneous Novo Nordisk Inc Labeling Revision
Tysabri natalizumab Vial; Single-Use Biogen Idec Supplement

 

September 21, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Aciphex rabeprazole sodium Tablet, Delayed Release;Oral Eisai Inc Manufacturing Change or Addition
Amidate etomidate Injectable;Injection Hospira Manufacturing Change or Addition
Argatroban argatroban Injectable;Injection Hospira Inc Approval
Drospirenone and Ethinyl Estradiol drospirenone; ethinyl estradiol Tablet;Oral-28 Apotex Inc Approval
Infuvite Pediatric (Pharmacy Bulk Package) ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k Injectable;Iv (Infusion) Sandoz Manufacturing Change or Addition
Mannitol 10% mannitol Injectable;Injection Hospira Manufacturing Change or Addition
Mannitol 15% mannitol Injectable;Injection Hospira Manufacturing Change or Addition
Mannitol 20% mannitol Injectable;Injection Hospira Manufacturing Change or Addition
Mannitol 25% mannitol Injectable;Injection Hospira Manufacturing Change or Addition
Mannitol 5% mannitol Injectable;Injection Hospira Manufacturing Change or Addition
Ms Contin morphine sulfate Tablet, Extended Release;Oral Purdue Pharma Lp Manufacturing Change or Addition
Orfadin nitisinone Capsule;Oral Swedish Orphan Manufacturing Change or Addition
Prevacid lansoprazole Tablet, Delayed Release, Orally Disintegrating;Oral Takeda Pharms Usa Manufacturing Change or Addition
Sancuso granisetron Film, Extended Release;Transdermal Kyowa Kirin Manufacturing Change or Addition
Tagrisso osimertinib mesylate Tablet;Oral Astrazeneca Pharms Manufacturing Change or Addition
Trimethoprim trimethoprim Tablet;Oral Mayne Pharma Manufacturing Change or Addition
Zydelig idelalisib Tablet;Oral Gilead Sciences Inc Labeling Revision

 

September 20, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Alecensa alectinib hydrochloride Capsule;Oral Hoffmann-La Roche Manufacturing Change or Addition
Anzemet dolasetron mesylate Tablet;Oral Us Pharm Holdings Manufacturing Change or Addition
Benicar Hct hydrochlorothiazide; olmesartan medoxomil Tablet;Oral Daiichi Sankyo Manufacturing Change or Addition
Bicnu carmustine Injectable;Injection Emcure Pharms Ltd Manufacturing Change or Addition
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride Syrup;Oral Acella Pharms Llc Approval
Bunavail buprenorphine hydrochloride; naloxone hydrochloride Film;Buccal Biodelivery Sci Intl Manufacturing Change or Addition
Epaned enalapril maleate Solution;Oral Silvergate Pharms Approval
Invokamet Xr canagliflozin;metformin hydrochloride Tablet, Extended Release;Oral Janssen Pharms Approval
Lotronex alosetron hydrochloride Tablet;Oral Sebela Ireland Ltd Manufacturing Change or Addition
Valsartan valsartan Tablet;Oral Macleods Pharms Ltd Approval
Victoza liraglutide recombinant Solution;Subcutaneous Novo Nordisk Inc Supplement

 

Page Last Updated: 09/28/2016
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