What's New on the FDA Drugs Site
August 14, 2012
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FDA Small Business Regulatory Education for Industry (REdI) Conference Fall 2012, September 19-20, 2012, Washington Marriott Wardman Park, Washington, DC. Meeting Information
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Atracurium besylate (updated)
- Drug Shortages: Current Drug Shortages: Aquasol A (updated)
- Drug Shortages: Current Drug Shortages: Acetylcysteine Inhalation Solution (updated)
- Drug Shortages: Current Drug Shortages: Ammonium Chloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Amphetamine Mixed Salts Immediate-Release Tablets (updated)
- Drug Shortages: Current Drug Shortages: Bumetanide Injection (updated)
- Drug Shortages: Current Drug Shortages: Bupivacaine Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Butorphanol Injection (updated)
- Drug Shortages: Current Drug Shortages: Desmopressin Injection (updated)
- Drug Shortages: Current Drug Shortages: Dextroamphetamine Tablets (updated)
- Drug Shortages: Current Drug Shortages: Diazepam Injection (updated)
- Drug Shortages: Current Drug Shortages: Epinephrine Injection (updated)
- Drug Shortages: Current Drug Shortages: Etomidate Injection (updated)
- Drug Shortages: Current Drug Shortages: Fentanyl Citrate Injection (updated
- Drug Shortages: Current Drug Shortages: Furosemide Injection (updated)
- Drug Shortages: Current Drug Shortages: Hydromorphone Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Isoniazid Tablets (updated)
- Drug Shortages: Current Drug Shortages: Methotrexate Injection (updated)
- Drug Shortages: Current Drug Shortages: Nefazodone Tablets (updated)
- Drug Shortages: Current Drug Shortages: Lidocaine HCL, 4% Topical Solution (updated)
- Drug Shortages: Current Drug Shortages: Lorazepam Injection (updated)
- Drug Shortages: Current Drug Shortages: Magnesium Sulfate Injection (updated)
- Drug Shortages: Current Drug Shortages: Methotrexate Injection (updated)
- Drug Shortages: Current Drug Shortages: Morphine Sulfate Injection (updated)
- Drug Shortages: Current Drug Shortages: Naloxone Injection (updated)
- Drug Shortages: Current Drug Shortages: Ondansetron Injection 2 mg/mL (updated)
- Drug Shortages: Current Drug Shortages: Pentostatin for Injection (Nipent) (updated)
- Drug Shortages: Current Drug Shortages: Potassium Chloride Injection 2 mEq/mL (updated)
- Drug Shortages: Current Drug Shortages: Procainamide HCL Injection (updated)
- Drug Shortages: Current Drug Shortages: Propofol Injection (updated)
- Drug Shortages: Current Drug Shortages: Sodium Acetate Injection (updated)
- Drug Shortages: Current Drug Shortages: Sodium Bicarbonate Injection (updated)
- Drug Shortages: Current Drug Shortages: Ticlopidine Tablets (updated)
- Drug Shortages: Current Drug Shortages: Viaspan Cold Storage Solution 1000 mL Bag (updated)
- Drug Shortages: Current Drug Shortages: Zinc Injection (updated)
- Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials
New and Generic Drug Approvals
August 13, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Actemra | tocilizumab | Injectable; Injection | Genentech | Supplement |
| An-Sulfur Colloid | technetium tc-99m sulfur colloid kit | Solution; Injection, Oral | Pharmalucence | Efficacy Supplement with Clinical Data to Support |
| Atelvia | risedronate sodium | Tablet, Delayed Release; Oral | Warner Chilcott Llc | Labeling Revision |
| Dexmethylphenidate Hydrochloride | dexmethylphenidate hydrochloride | Capsule, Extended Release; Oral | Mylan Pharms Inc | Tentative Approval |
| Lanoxin | digoxin | Tablet; Oral | Covis Pharma | Labeling Revision |
| Tradjenta | linagliptin | Tablet; Oral | Boehringer Ingelheim | Efficacy Supplement with Clinical Data to Support |
| Zestoretic | hydrochlorothiazide; lisinopril | Tablet; Oral | Astrazeneca | Labeling Revision |
| Zestril | lisinopril | Tablet; Oral | Astrazeneca | Labeling Revision |
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