What's New on the FDA Drugs Site
May 31, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Safety Podcast: FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor Due to Bone Changes in Exposed Babies
- Medication Guides (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (updated)
- National Drug Code Directory
New and Generic Drug Approvals
May 30, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Clonidine Hydrochloride | clonidine hydrochloride | Tablet, Extended Release; Oral | Anchen Pharms | Tentative Approval |
| Conray | iothalamate meglumine | Injectable; Injection | Mallinckrodt | Manufacturing Change or Addition |
| Conray 43 | iothalamate meglumine | Injectable; Injection | Mallinckrodt | Manufacturing Change or Addition |
| Cysto-Conray | iothalamate meglumine | Solution; Intravesical, Ureteral | Mallinckrodt | Manufacturing Change or Addition |
| Cysto-Conray Ii | iothalamate meglumine | Solution; Intravesical | Mallinckrodt | Manufacturing Change or Addition |
| Dutasteride | dutasteride | Capsule; Oral | Banner Pharmacaps | Approval |
| Fanapt | iloperidone | Tablet; Oral | Novartis | Manufacturing Change or Addition |
| Humulin 70/30 | insulin recombinant human; insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin 70/30 Pen | insulin recombinant human; insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin N | insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin R | insulin recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin R Pen | insulin recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Kepivance | palifermin | Injectable; Injection | Biovitrum Ab | Labeling Revision |
| Nesina | alogliptin benzoate | Tablet; Oral | Takeda Pharms Usa | Manufacturing Change or Addition |
| Nplate | romiplostim | Injectable; Subcutaneous | Amgen | Labeling Revision |
| Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Rapamune | sirolimus | Solution; Oral | Wyeth Pharms Inc | Labeling Revision |
| Rapamune | sirolimus | Tablet; Oral | Wyeth Pharms Inc | Labeling Revision |
| Uroxatral | alfuzosin hydrochloride | Tablet, Extended Release; Oral | Covis Pharma Sarl | 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 |  |
