What's New on the FDA Drugs Site
December 23, 2014
- FDA Drug Shortages: New and Updated
- Newly Added Generic Name or Active Ingredient
- Quazepam (Doral) Tablets (Currently in Shortage)
- Updated
- Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
- Newly Added Generic Name or Active Ingredient
- Bioequivalence Recommendations for Specific Products: Methylphenidate HCl (PDF - 38KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
New and Generic Drug Approvals
December 22, 2014
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Cordarone | amiodarone hydrochloride | Tablet;Oral | Wyeth Pharms Inc | Labeling Revision |
Dextrose 10% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Dextrose 20% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Dextrose 30% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Dextrose 40% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Dextrose 5% and Potassium Chloride 0.075% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Dextrose 5% and Potassium Chloride 0.15% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Dextrose 5% and Potassium Chloride 0.224% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Dextrose 5% and Potassium Chloride 0.3% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Dextrose 5% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Dextrose 50% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Dextrose 50% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Dextrose 60% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Dextrose 60% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Dextrose 70% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Dextrose 70% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Extavia | interferon beta-1b | Injectable; Subcutaneous | Novartis Pharms | Labeling Revision |
Opdivo | nivolumab | Injectable;Injection | Bristol Myers Squibb | Approval |
Plasma-Lyte 56 and Dextrose 5% In Plastic Container | dextrose; magnesium acetate tetrahydrate; potassium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Potassium Chloride | potassium chloride | Solution; Oral | Pharma-Med Inc | Approval |
Remodulin | treprostinil | Injectable;Iv (Infusion), Subcutaneous | United Therap | Labeling Revision |
Sodium Chloride 0.45% In Plastic Container | sodium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Sodium Chloride 0.9% In Plastic Container | sodium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Sodium Chloride 3% In Plastic Container | sodium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Sodium Chloride 5% In Plastic Container | sodium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
Somatuline Depot | lanreotide acetate | Injectable;Subcutaneous | Ipsen Pharma | Labeling Revision |
Tykerb | lapatinib ditosylate | Tablet;Oral | Smithkline Beecham | Labeling Revision |
December 19, 2014
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Acetazolamide Sodium | acetazolamide sodium | Injectable;Injection | Emcure Pharms Ltd | Approval |
Aciphex | rabeprazole sodium | Tablet, Delayed Release;Oral | Eisai Inc | Labeling Revision |
Aciphex Sprinkle | rabeprazole sodium | Capsule, Delayed Release;Oral | Eisai Inc | Labeling Revision |
Camptosar | irinotecan hydrochloride | Injectable;Injection | Pfizer Inc | Labeling Revision |
Clozaril | clozapine | Tablet;Oral | Novartis | Labeling Revision |
Cutivate | fluticasone propionate | Lotion;Topical | Fougera Pharms | Manufacturing Change or Addition |
Dexilant | dexlansoprazole | Capsule, Delayed Release;Oral | Takeda Pharms Usa | Labeling Revision |
Erwinaze | asparaginase erwinia chrysanthemi | Injectable; Injection | Eusa Pharma Usa | Labeling Revision |
Esomeprazole Strontium | esomeprazole strontium | Capsule, Delayed Release;Oral | Hanmi Pharm Co Ltd | Labeling Revision |
Estradiol | estradiol | Film, Extended Release;Transdermal | Mylan Technologies | Approval |
Ganirelix Acetate | ganirelix acetate | Injectable;Injection | Organon Usa Inc | Labeling Revision |
Halaven | eribulin mesylate | Solution;Intravenous | Eisai Inc | Labeling Revision |
Lynparza | olaparib | Capsule; Oral | Astrazeneca Lp | Approval |
Merrem | meropenem | Injectable;Injection | Astrazeneca | Labeling Revision |
Nexium | esomeprazole magnesium | Capsule, Delayed Rel Pellets;Oral | Astrazeneca | Labeling Revision |
Nexium | esomeprazole magnesium | For Suspension, Delayed Release;Oral | Astrazeneca | Labeling Revision |
Nexium | esomeprazole magnesium | For Suspension, Delayed Release;Oral | Astrazeneca | Labeling Revision |
Nexium Iv | esomeprazole sodium | Injectable;Intravenous | Astrazeneca | Labeling Revision |
Prevacid | lansoprazole | Capsule, Delayed Rel Pellets;Oral | Takeda Pharms Usa | Labeling Revision |
Prevacid | lansoprazole | Tablet, Delayed Release, Orally Disintegrating;Oral | Takeda Pharms Usa | Labeling Revision |
Prevpac | amoxicillin; clarithromycin; lansoprazole | Capsule, Capsule, Delayed Rel Pellets, Tablet;Oral | Takeda Pharms Usa | Labeling Revision |
Prilosec | omeprazole | Capsule, Delayed Rel Pellets;Oral | Astrazeneca | Labeling Revision |
Prilosec | omeprazole magnesium | For Suspension, Delayed Release;Oral | Astrazeneca | Labeling Revision |
Protonix | pantoprazole sodium | Tablet, Delayed Release;Oral | Wyeth Pharms Inc | Labeling Revision |
Protonix | pantoprazole sodium | For Suspension, Delayed Release;Oral | Wyeth Pharms Inc | Labeling Revision |
Protonix Iv | pantoprazole sodium | Injectable;Iv (Infusion) | Wyeth Pharms Inc | Labeling Revision |
Rapivab | peramivir | Injectable;Iv (Infusion) | Biocryst Pharmaceuticals Inc | Approval |
Simponi | golimumab | Injectable; Injection | Centocor Ortho Biotech Inc | Labeling Revision |
Simponi Aria | golimumab | Injectable; Injection | Janssen Biotech | Labeling Revision |
Soolantra | ivermectin | Cream;Topical | Galderma Res and Dev Llc | Approval |
Sutent | sunitinib malate | Capsule;Oral | Cppi Cv | Labeling Revision |
Symbyax | fluoxetine hydrochloride; olanzapine | Capsule;Oral | Lilly | Labeling Revision |
Tbo-Filgrastim | tbo-filgrastim | Injectable; Injection | Sicor Biotech | Labeling Revision |
Tivicay | dolutegravir sodium | Tablet;Oral | Viiv Hlthcare | Labeling Revision |
Trulicity | dulaglutide | Injectable;Injection | Eli Lilly and Co | Labeling Revision |
Ventolin Hfa | albuterol sulfate | Aerosol, Metered;Inhalation | Glaxosmithkline | Labeling Revision |
Viekira Pak | ombitasivr; paritaprevir; ritonavir; dasabuvir | Tablet, Tablet;Oral | Abbvie Inc | Approval |
Vimovo | esomeprazole magnesium; naproxen | Tablet, Delayed Release;Oral | Horizon Pharma | Labeling Revision |
Xarelto | rivaroxaban | Tablet;Oral | Janssen Pharms | Labeling Revision |
Zegerid | omeprazole; sodium bicarbonate | For Suspension;Oral | Santarus Inc | Labeling Revision |
Zegerid | omeprazole; sodium bicarbonate | Capsule;Oral | Santarus Inc | Labeling Revision |
Zerbaxa | ceftolozane;tazobactam | Injectable;Injection | Cubist Pharms Inc | Approval |
Zyprexa | olanzapine | Tablet;Oral | Lilly | Labeling Revision |
Zyprexa | olanzapine | Injectable;Intramuscular | Lilly | Labeling Revision |
Zyprexa Relprevv | olanzapine pamoate | Suspension, Extended Release;Intramuscular | Eli Lilly Co | Labeling Revision |
Zyprexa Zydis | olanzapine | Tablet, Orally Disintegrating;Oral | Lilly | Labeling Revision |
December 18, 2014
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Afinitor | everolimus | Tablet;Oral | Novartis | Efficacy Supplement with Clinical Data to Support |
Ammonia N-13 | ammonia n 13 | Injectable;Intravenous | Wi Medcl Cyclotron | Approval |
Bupropion Hydrochloride | bupropion hydrochloride | Tablet, Extended Release;Oral | Sun Pharma Global | Approval |
Fludeoxyglucose F18 | fludeoxyglucose f-18 | Injectable;Intravenous | Shertech Labs Llc | Approval |
Lamivudine | lamivudine | Tablet;Oral | Lupin Ltd | Approval |
Magnesium Sulfate | magnesium sulfate | Injectable;Injection | Exela Pharma Scs Llc | Approval |
Oxycodone Hydrochloride and Acetaminophen | acetaminophen; oxycodone hydrochloride | Solution;Oral | Vintage Pharms | Approval |
Topamax | topiramate | Tablet;Oral | Janssen Pharms | Labeling Revision |
Topamax | topiramate | Capsule;Oral | Janssen Pharms | Labeling Revision |
Topamax Sprinkle | topiramate | Capsule;Oral | Janssen Pharms | Labeling Revision |