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 |
| This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
