What's New on the FDA Drugs Site
June 20, 2012
- DIA/FDA: Revitalizing Productivity in Drug Development, October 23, 2012, 5151 Pooks Hill Road, Bethesda, MD. Meeting information and registration
- Drug Firm Annual Registration Status Download File
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Alfentanil Injection (updated)
- Drug Shortages: Current Drug Shortages: Calcitriol 1 mcg/mL Injection (updated)
- Drug Shortages: Current Drug Shortages: Chloroprocaine (Nesacaine) Injection (updated)
- Drug Shortages: Current Drug Shortages: Diltiazem Injection (updated)
- Drug Shortages: Current Drug Shortages: Diphenhydramine Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Fentanyl Citrate Injection (updated)
- Drug Shortages: Current Drug Shortages: Hydromorphone Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Lidocaine Hydrochloride Injection (updated)
- Drug Shortages:Current Drug Shortages: Lorazepam Injection (updated)
- Drug Shortages: Current Drug Shortages: Midazolam Injection (updated)
- Drug Shortages: Current Drug Shortages: Nefazodone Tablets (updated)
- Drug Shortages: Current Drug Shortages: Ondansetron Injection 2 mg/ML (updated)
- Drug Shortages: Current Drug Shortages: Orphenadrine Citrate 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: Sufentanil Injection (updated)
- Drug Shortages: Current Drug Shortages: Tobramycin Solution for Injection (updated)
- From a Clinical Perspective: Enrichment Design Studies Should Enhance Signals of Effectiveness (by Robert Temple, M.D., Deputy Director for Clinical Science)
- Table of Pharmacogenomic Biomarkers in Drug Labels (updated)
New and Generic Drug Approvals
June 19, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Helidac | bismuth subsalicylate; metronidazole; tetracycline hydrochloride | Tablet, Chewable, Tablet, Capsule; Oral | Prometheus Labs | Labeling Revision |
| Helidac | bismuth subsalicylate; metronidazole; tetracycline hydrochloride | Tablet, Chewable, Tablet, Capsule; Oral | Prometheus Labs | Manufacturing Change or Addition |
| Olanzapine; Fluoxetine Hydrochloride | olanzapine; fluoxetine hydrochloride | Capsule; Oral | Teva Pharms | Approval |
| Sumatriptan Succinate | sumatriptan succinate | Tablet; Oral | Apotex Inc | Approval |
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