What's New on the FDA Drugs Site
April 29, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Manual of Policies and Procedures (MAPP) 6030.9 Good Review Practice: Good Review Management Principles and Practices for Effective IND Development and Review(PDF - 297KB)
- National Drug Code Directory (updated)
New and Generic Drug Approvals
April 28, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Children's Allegra Allergy | fexofenadine hydrochloride | Tablet, Orally Disintegrating; Oral | Sanofi Aventis Us | Labeling Revision |
| Children's Allegra Allergy | fexofenadine hydrochloride | Suspension; Oral | Sanofi Aventis Us | Labeling Revision |
| Children's Allegra Hives | fexofenadine hydrochloride | Tablet, Orally Disintegrating; Oral | Sanofi Aventis Us | Labeling Revision |
| Children's Allegra Hives | fexofenadine hydrochloride | Suspension; Oral | Sanofi Aventis Us | Labeling Revision |
April 26, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Atacand | candesartan cilexetil | Tablet; Oral | Astrazeneca | Labeling Revision |
| Atacand Hct | candesartan cilexetil; hydrochlorothiazide | Tablet; Oral | Astrazeneca | Labeling Revision |
| Claritin-D 24 Hour | loratadine; pseudoephedrine sulfate | Tablet, Extended Release; Oral | Schering Plough | Manufacturing Change or Addition |
| Dextrose 5% and Electrolyte No.48 In Plastic Container | dextrose; magnesium chloride; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium lactate | Injectable; Injection | Baxter Hlthcare | 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 | Manufacturing Change or Addition |
| Dianeal 137 W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal 137 W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Low Calcium W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Low Calcium W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Low Calcium W/ Dextrose 3.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Low Calcium W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-1 W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-1 W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-1 W/ Dextrose 3.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-1 W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-2 W/ Dextrose 3.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Edurant | rilpivirine hydrochloride | Tablet; Oral | Janssen Prods | Manufacturing Change or Addition |
| Extraneal | icodextrin | Solution; Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Glucagen | glucagon hydrochloride recombinant | Injectable; Injection | Novo Nordisk | Labeling Revision |
| Glucagen | glucagon hydrochloride recombinant | Injectable; Injection | Novo Nordisk | Manufacturing Change or Addition |
| Lactated Ringer's and Dextrose 5% In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Lactated Ringer's In Plastic Container | calcium chloride; potassium chloride; sodium chloride; sodium lactate | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Lactated Ringer's In Plastic Container | calcium chloride; potassium chloride; sodium chloride; sodium lactate | Solution; Irrigation | Baxter Hlthcare | Manufacturing Change or Addition |
| Levalbuterol Hydrochloride | levalbuterol hydrochloride | Solution; Inhalation | Teva Pharms Usa | Approval |
| Potassium Chloride 10meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Potassium Chloride 15meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Potassium Chloride 20meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Potassium Chloride 30meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Potassium Chloride 40meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Potassium Chloride 5meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Salagen | pilocarpine hydrochloride | Tablet; Oral | Eisai Inc | Manufacturing Change or Addition |
| Sodium Lactate 0.167 Molar In Plastic Container | sodium lactate | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Totect | dexrazoxane hydrochloride | Injectable; Injection | Apricus Pharms | Labeling Revision |
| Vyvanse | lisdexamfetamine dimesylate | Capsule; Oral | Shire Development | Efficacy Supplement with Clinical Data to Support |
April 24, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Colyte | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | For Solution; Oral | Meda Pharms | Manufacturing Change or Addition |
| Colyte With Flavor Packs | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | For Solution; Oral | Meda Pharms | Manufacturing Change or Addition |
| Colyte-Flavored | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | For Solution; Oral | Meda Pharms | Manufacturing Change or Addition |
| Cutivate | fluticasone propionate | Lotion; Topical | Fougera Pharms | Manufacturing Change or Addition |
| Estradiol | estradiol | Film, Extended Release; Transdermal | Novartis | Manufacturing Change or Addition |
| Famvir | famciclovir | Tablet; Oral | Novartis | Labeling Revision |
| Humira | adalimumab | Syringe | Abbott | Manufacturing Change or Addition |
| Humira | adalimumab | Vial | Abbott | Manufacturing Change or Addition |
| Jalyn | dutasteride; tamsulosin hydrochloride | Capsule; Oral | Glaxosmithkline | Labeling Revision |
| Prezista | darunavir ethanolate | Tablet; Oral | Janssen Prods | Efficacy Supplement with Clinical Data to Support |
| Prezista | darunavir ethanolate | Suspension; Oral | Janssen Prods | Efficacy Supplement with Clinical Data to Support |
| Pirmella 1/35 | ethinyl estradiol; norethindrone | Tablet; Oral | Lupin Ltd | Approval |
| Pirmella 7/7/7 | ethinyl estradiol; norethindrone | Tablet; Oral | Lupin Ltd | Approval |
| Promethazine Hydrochloride and Codeine Phosphate | codeine phosphate; promethazine hydrochloride | Syrup; Oral | Amneal Pharms | Approval |
| Vivelle-Dot | estradiol | Film, Extended Release; Transdermal | Novartis | Manufacturing Change or Addition |
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