What's New on the FDA Drugs Site
April 22, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA announces voluntary nationwide recall by Balanced Solutions Compounding Pharmacy
- National Drug Code Directory (updated)
- Office of Prescription Drug Promotion (OPDP) Launches (updated)
- Paragraph IV Patent Certifications (updated)
- Safe Use Initiative: Funding and Support (updated)
- Warning Letters 2013 (updated)
New and Generic Drug Approvals
April 19, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aciphex | rabeprazole sodium | Tablet, Delayed Release; Oral | Eisai Inc | Labeling Revision |
| Actonel | risedronate sodium | Tablet; Oral | Warner Chilcott Llc | Labeling Revision |
| Actonel With Calcium (Copackaged) | calcium carbonate; risedronate sodium | Tablet, Tablet; Oral | Warner Chilcott | Labeling Revision |
| Amaryl | glimepiride | Tablet; Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Ambien | zolpidem tartrate | Tablet; Oral | Sanofi Aventis Us | Labeling Revision |
| Ambien Cr | zolpidem tartrate | Tablet, Extended Release; Oral | Sanofi Aventis Us | Labeling Revision |
| Amitiza | lubiprostone | Capsule; Oral | Sucampo Pharms | Efficacy Supplement with Clinical Data to Support |
| Atelvia | risedronate sodium | Tablet, Delayed Release; Oral | Warner Chilcott Llc | Labeling Revision |
| Bactocill In Plastic Container | oxacillin sodium | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Binosto | alendronate sodium | Tablet, Effervescent; Oral | Mission Pharma | Labeling Revision |
| Boniva | ibandronate sodium | Tablet; Oral | Hoffmann La Roche | Labeling Revision |
| Boniva | ibandronate sodium | Injectable; Intravenous | Roche | Labeling Revision |
| Complera | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | Tablet; Oral | Gilead Sciences Inc | Manufacturing Change or Addition |
| Demerol | meperidine hydrochloride | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Dianeal 137 W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal 137 W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal 137 W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Low Calcium W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Low Calcium W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Low Calcium W/ Dextrose 3.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Low Calcium W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Pd-1 W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Pd-1 W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Pd-1 W/ Dextrose 3.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Pd-1 W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Pd-2 W/ Dextrose 3.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Didronel | etidronate disodium | Tablet; Oral | Procter and Gamble | Labeling Revision |
| Differin | adapalene | Lotion; Topical | Galderma Labs Lp | Labeling Revision |
| Doral | quazepam | Tablet; Oral | Questcor Pharms | Labeling Revision |
| Doral | quazepam | Tablet; Oral | Questcor Pharms | Manufacturing Change or Addition |
| Edluar | zolpidem tartrate | Tablet; Sublingual | Meda Pharms | Labeling Revision |
| Elocon | mometasone furoate | Cream; Topical | Merck Sharp Dohme | Efficacy Supplement with Clinical Data to Support |
| Fosamax | alendronate sodium | Tablet; Oral | Merck and Co Inc | Labeling Revision |
| Fosamax | alendronate sodium | Solution; Oral | Merck | Labeling Revision |
| Fosamax Plus D | alendronate sodium; cholecalciferol | Tablet; Oral | Merck | Labeling Revision |
| Genotropin | somatropin recombinant | Injectable; Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Genotropin Preservative Free | somatropin recombinant | Injectable; Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Kyprolis | carfilzomib | Powder; Intravenous | Onyx Pharms | Manufacturing Change or Addition |
| Lotronex | alosetron hydrochloride | Tablet; Oral | Prometheus Labs | Manufacturing Change or Addition |
| Metoclopramide Hydrochloride | metoclopramide hydrochloride | Injectable; Injection | Bd Rx | Approval |
| Minastrin 24 Fe | norethindrone acetate; ethinyl estradiol; ferrous fumarate | Capsule; Oral | Warner Chilcott Llc | Approval |
| Mycamine | micafungin sodium | Injectable; Injection | Astellas | Labeling Revision |
| Mycamine | micafungin sodium | Injectable; Iv (Infusion) | Astellas | Labeling Revision |
| Ofirmev | acetaminophen | Solution; Iv (Infusion) | Cadence Pharms | Manufacturing Change or Addition |
| Omeprazole and Sodium Bicarbonate | omeprazole; sodium bicarbonate | For Suspension; Oral | Par Pharm | Approval |
| Pristiq | desvenlafaxine succinate | Tablet, Extended Release; Oral | Wyeth Pharms Inc | Manufacturing Change or Addition |
| Prometrium | progesterone | Capsule; Oral | Abbott Labs | Manufacturing Change or Addition |
| Rabeprazole Sodium | rabeprazole sodium | Tablet, Delayed Release; Oral | Kremers Urban Pharms | Tentative Approval |
| Rebif | interferon beta-1a | Syringe | Serono Inc | Labeling Revision |
| Reclast | zoledronic acid | Injectable; Iv (Infusion) | Novartis | Labeling Revision |
| Simbrinza | brinzolamide; brimonidine tartrate | Suspension; Ophthalmic | Alcon Res Ltd | Approval |
| Sodium Chloride 0.9% In Plastic Container | sodium chloride | Solution; Irrigation | B Braun | Manufacturing Change or Addition |
| Sonata | zaleplon | Capsule; Oral | King Pharms | Labeling Revision |
| Trelstar | triptorelin pamoate | Injectable; Intramuscular | Watson Labs | Manufacturing Change or Addition |
| Valium | diazepam | Tablet; Oral | Roche | Manufacturing Change or Addition |
| Valsartan | valsartan | Tablet; Oral | Aurobindo Pharma Ltd | Tentative Approval |
| Valsartan and Hydrochlorothiazide | hydrochlorothiazide; valsartan | Tablet; Oral | Macleods Pharms Ltd | Approval |
| Vascepa | icosapent ethyl | Capsule; Oral | Amarin Pharma Inc | Manufacturing Change or Addition |
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