What's New on the FDA Drugs Site
July 6, 2012
- BPCA of 2007: List of Determinations including Written Request (updated)
- Drug Firm Annual Registration Status Download File
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Diphenhydramine Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Fluorouracil Injection (updated)
- Drug Shortages: Current Drug Shortages: Heparin Sodium Premixes
- Drug Shortages: Current Drug Shortages: Naloxone Injection (updated)
- MedWatch Safety Alert: Leucovorin Calcium Injection (Bedford Laboratories): Recall - Visible Particulate Matter
- Presentation: Patient-Focused Drug Development (PDF - 455KB)
- Prescription Drug User Fee Act (PDUFA): Regulations and Federal Register Documents (updated)
New and Generic Drug Approvals
July 6, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Erbitux | cetuximab | Vial; Intravenous | Imclone | Supplement |
July 5, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Azasite | azithromycin | Solution/Drops; Ophthalmic | Inspire | Labeling Revision |
| 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 |
| H.P. Acthar Gel | corticotropin | Injectable; Injection | Questcor Pharms | Labeling Revision |
| Prograf | tacrolimus | Capsule; Oral | Astellas | Labeling Revision |
| Prograf | tacrolimus | Injectable; Injection | Astellas | Labeling Revision |
| Strattera | atomoxetine hydrochloride | Capsule; Oral | Lilly | Labeling Revision |
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