What's New on the FDA Drugs Site
March 15, 2013
- Affordable Care Act (updated)
- Current Drug Shortages Index (updated)
New and Generic Drug Approvals
March 14, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amaryl | glimepiride | Tablet; Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Creon | pancrelipase (amylase;lipase;protease) | Capsule, Delayed Release; Oral | Abbvie | Manufacturing Change or Addition |
| Cycloset | bromocriptine mesylate | Tablet; Oral | Veroscience | Manufacturing Change or Addition |
| Glucophage | metformin hydrochloride | Tablet; Oral | Bristol Myers Squibb | Manufacturing Change or Addition |
| Glucovance | glyburide; metformin hydrochloride | Tablet; Oral | Bristol Myers Squibb | Manufacturing Change or Addition |
| Humalog | insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Kwikpen | insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Pen | insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Lidocaine Hydrochloride Preservative Free | lidocaine hydrochloride | Injectable; Injection | Aurobindo Pharma Ltd | Approval |
| Lidocaine Hydrochloride Preservative Free | lidocaine hydrochloride | Injectable; Injection | Aurobindo Pharma Ltd | Approval |
| Lopressor | metoprolol tartrate | Tablet; Oral | Us Pharms Holdings I | Labeling Revision |
| Lopressor | metoprolol tartrate | Injectable; Injection | Novartis | Labeling Revision |
| Micro-K | potassium chloride | Capsule, Extended Release; Oral | Nesher Pharms | Manufacturing Change or Addition |
| Micro-K 10 | potassium chloride | Capsule, Extended Release; Oral | Nesher Pharms | Manufacturing Change or Addition |
| Technescan | technetium tc-99m oxidronate kit | Injectable; Injection | Mallinckrodt | Manufacturing Change or Addition |
| Xopenex Hfa | levalbuterol tartrate | Aerosol, Metered; Inhalation | Sunovion | Manufacturing Change or Addition |
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