What's New on the FDA Drugs Site
October 28, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- National Drug Code Directory
New and Generic Drug Approvals
October 26, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Sabril | vigabatrin | Tablet;Oral | Lundbeck Llc | Efficacy Supplement with Clinical Data to Support |
| Sabril | vigabatrin | Tablet;Oral | Lundbeck Llc | Labeling Revision |
| Sabril | vigabatrin | For Solution;Oral | Lundbeck Llc | Efficacy Supplement with Clinical Data to Support |
| Sabril | vigabatrin | For Solution;Oral | Lundbeck Llc | Labeling Revision |
October 25, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Accupril | quinapril hydrochloride | Tablet;Oral | Pfizer Pharms | Labeling Revision |
| Accuretic | hydrochlorothiazide; quinapril hydrochloride | Tablet;Oral | Pfizer Pharms | Labeling Revision |
| Altace | ramipril | Capsule;Oral | King Pharms | Labeling Revision |
| Amyvid | florbetapir f-18 | Solution;Intravenous | Avid Radiopharms Inc | Manufacturing Change or Addition |
| Apriso | mesalamine | Capsule, Extended Release;Oral | Salix Pharms | Manufacturing Change or Addition |
| Calan | verapamil hydrochloride | Tablet;Oral | Gd Searle Llc | Labeling Revision |
| Juvisync | simvastatin; sitagliptin phosphate | Tablet;Oral | Merck Sharp Dohme | Labeling Revision |
| Rayos | prednisone | Tablet, Delayed Release;Oral | Horizon Pharma | Manufacturing Change or Addition |
| Ritalin | methylphenidate hydrochloride | Tablet;Oral | Novartis | Manufacturing Change or Addition |
| Ritalin La | methylphenidate hydrochloride | Capsule, Extended Release;Oral | Novartis | Manufacturing Change or Addition |
| Ritalin-Sr | methylphenidate hydrochloride | Tablet, Extended Release;Oral | Novartis | Manufacturing Change or Addition |
| Vizamyl | flutemetamol f 18 | Injectable;Iv | Ge Hlthcare Inc | Approval |
| Vytorin | ezetimibe; simvastatin | Tablet;Oral | Msd Intl | Labeling Revision |
| Zaltrap | ziv-aflibercept | Injectable; Injection | Sanofi Aventis Us | Labeling Revision |
| Zocor | simvastatin | Tablet;Oral | Merck | Labeling Revision |
| Zohydro Er | hydrocodone bitartrate | Capsule, Extended Release;Oral | Zogenix Inc | Approval |
| Zyprexa | olanzapine | Tablet;Oral | Lilly | Manufacturing Change or Addition |
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