Drugs

New and Generic Drug Approvals

 

July 22, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Brilinta ticagrelor Tablet;Oral Astrazeneca Lp Labeling Revision
Cerezyme imiglucerase Injectable;Injection Genzyme Manufacturing Change or Addition
Movantik naloxegol oxalate Tablet;Oral Astrazeneca Pharms Labeling Revision
Omtryg omega-3-acid ethyl esters type a Capsule;Oral Trygg Manufacturing Change or Addition
Rayos prednisone Tablet, Delayed Release;Oral Horizon Pharma Manufacturing Change or Addition
Sandostatin Lar octreotide acetate Injectable;Injection Novartis Manufacturing Change or Addition
Temozolomide temozolomide Capsule;Oral Amerigen Pharms Ltd Approval
Viekira Xr dasabuvir;ombitasvir;paritaprevir;ritonavir Tablet, Extended Release;Oral Abbvie Approval

 

July 21, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Achromycin V tetracycline hydrochloride Capsule;Oral Heritage Pharms Inc Manufacturing Change or Addition
Halaven eribulin mesylate Solution;Intravenous Eisai Inc Manufacturing Change or Addition
Ilaris canakinumab Injectable; Subcutaneous Novartis Pharms Efficacy Supplement with Clinical Data to Support
Irbesartan and Hydrochlorothiazide hydrochlorothiazide; irbesartan Tablet;Oral Mylan Pharms Inc Approval
Relenza zanamivir Powder;Inhalation Glaxosmithkline Manufacturing Change or Addition

 

July 20, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Clinolipid 20% olive oil; soybean oil Injectable;Injection Baxter Hlthcare Labeling Revision
Eliquis apixaban Tablet;Oral Bristol Myers Squibb Labeling Revision
Epivir lamivudine Tablet;Oral Viiv Hlthcare Efficacy Supplement with Clinical Data to Support
Epivir lamivudine Solution;Oral Viiv Hlthcare Efficacy Supplement with Clinical Data to Support
Furosemide furosemide Injectable;Injection Amneal Pharms Co Approval
Jenloga clonidine hydrochloride Tablet, Extended Release;Oral Concordia Pharms Inc Manufacturing Change or Addition
Kapvay clonidine hydrochloride Tablet, Extended Release;Oral Concordia Pharms Inc Manufacturing Change or Addition
Phoxillum B22k 4/0 In Plastic Container calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate Injectable;Injection Baxter Hlthcare Labeling Revision
Phoxillum Bk 4/2.5 In Plastic Container calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol B22gk 2/0 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol B22gk 2/2.5 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol B22gk 4/0 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol B22gk 4/2.5 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol Bgk 0/2.5 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol Bgk 2/0 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol Bgk 2/3.5 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol Bgk 4/0 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol Bgk 4/0/1.2 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol Bgk 4/2.5 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol Bgk 4/3.5 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol Bk 0/0 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol Bk 0/0/1.2 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol Bk 0/3.5 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Prismasol Bk 4/2.5 In Plastic Container calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Yondelis trabectedin Powder;Iv (Infusion) Janssen Prods Labeling Revision

 

July 19, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Dalfampridine dalfampridine Tablet;Oral Teva Pharms Usa Inc Tentative Approval
Doxylamine Succinate; Pyridoxine Hydrochloride doxylamine succinate;pyridoxine hydrochloride Tablet, Delayed Release;Oral Actavis Labs Fl Inc Tentative Approval
Esomeprazole Sodium esomeprazole sodium Injectable;Injection Deva Holding A.S. Tentative Approval
Indomethacin indomethacin Capsule;Oral Mylan Manufacturing Change or Addition
Relistor methylnaltrexone bromide Tablet;Oral Salix Pharms Approval
Rosuvastatin Calcium rosuvastatin calcium Tablet;Oral Apotex Inc Approval
Rosuvastatin Calcium rosuvastatin calcium Tablet;Oral Mylan Pharms Inc Approval
Rosuvastatin Calcium rosuvastatin calcium Tablet;Oral Teva Pharms Usa Approval
Rosuvastatin Calcium rosuvastatin calcium Tablet;Oral Par Pharm Inc Approval
Rosuvastatin Calcium rosuvastatin calcium Tablet;Oral Sun Pharma Global Approval
Rosuvastatin Calcium rosuvastatin calcium Tablet;Oral Aurobindo Pharma Ltd Approval
Rosuvastatin Calcium rosuvastatin calcium Tablet;Oral Sandoz Inc Approval
Rosuvastatin Calcium rosuvastatin calcium Tablet;Oral Glenmark Pharms Ltd Approval
Valganciclovir Hydrochloride valganciclovir hydrochloride For Solution;Oral Actavis Labs Fl Inc Approval
Zoladex goserelin acetate Implant;Implantation Astrazeneca Manufacturing Change or Addition

 

July 18, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Delflex W/ Dextrose 1.5% In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 2.5% In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 4.25% In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container heparin sodium Injectable;Injection Hospira Manufacturing Change or Addition
Heparin Sodium 10,000 Units In Sodium Chloride 0.45% heparin sodium Injectable;Injection Hospira Manufacturing Change or Addition
Heparin Sodium 10,000 Units In Sodium Chloride 0.9% heparin sodium Injectable;Injection Hospira Manufacturing Change or Addition
Heparin Sodium 12,500 Units In Sodium Chloride 0.45% In Plastic Container heparin sodium Injectable;Injection Hospira Manufacturing Change or Addition
Heparin Sodium 12,500 Units In Sodium Chloride 0.9% heparin sodium Injectable;Injection Hospira Manufacturing Change or Addition
Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container heparin sodium Injectable;Injection Hospira Manufacturing Change or Addition
Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container heparin sodium Injectable;Injection Hospira Manufacturing Change or Addition
Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Container heparin sodium Injectable;Injection Hospira Manufacturing Change or Addition
Heparin Sodium 5,000 Units In Sodium Chloride 0.45% heparin sodium Injectable;Injection Hospira Manufacturing Change or Addition
Heparin Sodium 5,000 Units In Sodium Chloride 0.9% heparin sodium Injectable;Injection Hospira Manufacturing Change or Addition
Namzaric donepezil hydrochloride; memantine hydrochloride Capsule, Extended Release;Oral Forest Labs Llc Efficacy Supplement with Clinical Data to Support
Penicillin G Potassium In Plastic Container penicillin g potassium Injectable;Injection Baxter Hlthcare Labeling Revision
Veletri epoprostenol sodium Injectable;Injection Actelion Pharms Ltd Manufacturing Change or Addition
Vimpat lacosamide Solution;Intravenous Ucb Inc Manufacturing Change or Addition

Page Last Updated: 07/25/2016
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