What's New on the FDA Drugs Site
June 7, 2012
- Drug Firm Annual Registration Status Download File
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Boniva (ibandronate sodium) Injection
- Drug Shortages: Current Drug Shortages: Dexrazoxane Injection (updated)
- Drug Shortages: Current Drug Shortages: Diphenhydramine Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Fentanyl Citrate Injection, USP 50 mcg/mL (updated)
- Drug Shortages: Current Drug Shortages: Fluorouracil Injection (updated)
- Drug Shortages: Current Drug Shortages: Methotrexate Injection (updated)
- Drug Shortages: Current Drug Shortages: Midazolam Injection (updated)
- Drug Shortages: Current Drug Shortages: Oxytocin Injection, USP (synthetic) (updated)
- Drug Shortages: Current Drug Shortages: Phentolamine Mesylate (updated)
- Drug Shortages: Current Drug Shortages: Sodium Bicarbonate Injection (updated)
- MedWatch Safety Alert: Introvale (levonorgestrel and ethinyl estradiol) Tablets: Recall - Packaging Flaw
- BPCA of 2007: List of Determinations including Written Request (updated)
- Pediatric Statistics: Pediatric Exclusivity Statistics (updated)
New and Generic Drug Approvals
June 6, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aggrastat | tirofiban hydrochloride | Injectable; Injection | Medicure | Labeling Revision |
| Aggrastat | tirofiban hydrochloride | Injectable; Injection | Medicure | Labeling Revision |
| Horizant | gabapentin enacarbil | Tablet, Extended Release; Oral | Glaxo Grp Ltd | Efficacy Supplement with Clinical Data to Support |
| Prinivil | lisinopril | Tablet; Oral | Merck | Labeling Revision |
| Prinzide | hydrochlorothiazide; lisinopril | Tablet; Oral | Merck | Labeling Revision |
| Ropinirole Hydrochloride | ropinirole hydrochloride | Tablet, Extended Release; Oral | Watson Labs Inc | Approval |
| Ropinirole Hydrochloride | ropinirole hydrochloride | Tablet, Extended Release; Oral | Sandoz Inc | Approval |
| Ropinirole Hydrochloride | ropinirole hydrochloride | Tablet, Extended Release; Oral | Dr Reddys Labs Ltd | Approval |
| Tridione | trimethadione | Capsule; Oral | Abbott | Labeling Revision |
| Tridione | trimethadione | Solution; Oral | Abbott | Labeling Revision |
| Tridione | trimethadione | Tablet; Oral | Abbott | Labeling Revision |
| Zithromax | azithromycin | For Suspension; Oral | Pfizer | Labeling Revision |
| Zithromax | azithromycin | For Suspension; Oral | Pfizer | Labeling Revision |
| Zithromax | azithromycin | Tablet; Oral | Pfizer | Labeling Revision |
| Zithromax | azithromycin | Tablet; Oral | Pfizer | Labeling Revision |
| Zithromax | azithromycin | Injectable; Injection | Pfizer | Labeling Revision |
| Zithromax | azithromycin | Tablet; Oral | Pfizer | Labeling Revision |
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