What's New on the FDA Drugs Site
May 4, 2012
- Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
- Drug Shortages: Current Drug Shortages: Cardiolite, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection
- Drug Shortages: Current Drug Shortages: Methylphenidate HCl (updated)
- Drug Shortages: Current Drug Shortages: Neurolite, Kit for the Preparation of Technetium Tc99m Bicisate for Injection
- Drug Shortages: Current Drug Shortages: Sodium Chloride 0.9% (5.8mL and 20mL)
- Drug Shortages: Current Drug Shortages: Xenon Xe 133 Gas
New and Generic Drug Approvals
May 3, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Avastin | bevacizumab | Vial; Intravenous | Genentech | Supplement |
| Biaxin | clarithromycin | Tablet; Oral | Abbott | Labeling Revision |
| Biaxin | clarithromycin | For Suspension; Oral | Abbott | Labeling Revision |
| Biaxin Xl | clarithromycin | Tablet, Extended Release; Oral | Abbott | Labeling Revision |
| Dexilant | dexlansoprazole | Capsule, Delayed Release; Oral | Takeda Pharms | Labeling Revision |
| Escitalopram Oxalate | escitalopram oxalate | Solution; Oral | Taro | Approval |
| Imodium A-D | loperamide hydrochloride | Tablet; Oral | Mcneil Cons | Labeling Revision |
| Imodium Multi-Symptom Relief | loperamide hydrochloride; simethicone | Tablet; Oral | Mcneil Cons | Labeling Revision |
| Prevacid | lansoprazole | Capsule, Delayed Rel Pellets; Oral | Takeda Pharms Usa | Labeling Revision |
| Prevacid | lansoprazole | Tablet, Delayed Release, Orally Disintegrating; Oral | Takeda Pharms Usa | Labeling Revision |
| Teflaro | ceftaroline fosamil | Powder; Iv (Infusion) | Cerexa | Manufacturing Change or Addition |
| Vardenafil Hydrochloride | vardenafil hydrochloride | Tablet; Oral | Teva Pharms | Approval |
| Zaditor | ketotifen fumarate | Solution/Drops; Ophthalmic | Alcon Pharma | Labeling Revision |
| Zarontin | ethosuximide | Capsule; Oral | Parke Davis | Labeling Revision |
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