What's New on the FDA Drugs Site
August 16, 2012
- FDA Drug Safety Podcast: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- MedWatch Safety Alert: Hospira Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject: Recall- May Contain More Than The Intended Fill Volume
- Prescription Drug User Fee Act (PDUFA) (updated): The FY 2013 Product and Establishment Fee Invoices were mailed Wednesday, August 15, 2012. Full payment of the invoice is due October 1, 2012. If you do not receive your invoice by August 27, 2012, please contact Ashley Jones or Beverly Friedman at 301-796-3602.
August 15, 2012
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death
- Drugs@FDA Download File (updated)
New and Generic Drug Approvals
August 15, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Bexxar | tositumomab; iodine i 131 tositumomab | Vial | SmithKline Beecham | Labeling Revision |
| E.E.S. | erythromycin ethylsuccinate | Tablet, Chewable; Oral | Arbor Pharms Inc | Labeling Revision |
| Eryped | erythromycin ethylsuccinate | Tablet, Chewable; Oral | Arbor Pharms Inc | Labeling Revision |
| Felodipine | felodipine | Tablet, Extended Release; Oral | Wockhardt Ltd | Approval |
| Ibandronate Sodium | ibandronate sodium | Tablet; Oral | Mutual Pharm Co Inc | Approval |
| Metoprolol Succinate | metoprolol succinate | Tablet, Extended Release; Oral | Reddys | Approval |
| Trobicin | spectinomycin hydrochloride | Injectable; Injection | Pfizer | Labeling Revision |
August 14, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aplenzin | bupropion hydrobromide | Tablet, Extended Release; Oral | Valeant Intl | Efficacy Supplement with Clinical Data to Support |
| Clobetasol Propionate | clobetasol propionate | Aerosol, Foam; Topical | Perrigo Israel | Approval |
| Clopidogrel Bisulfate | clopidogrel bisulfate | Tablet; Oral | Wockhardt Ltd | Approval |
| Clopidogrel Bisulfate | clopidogrel bisulfate | Tablet; Oral | Wockhardt Ltd | Tentative Approval |
| Demadex | torsemide | Tablet; Oral | Meda Pharms | Labeling Revision |
| Didanosine | didanosine | Tablet, Chewable; Oral | Aurobindo | Approval |
| Prograf | tacrolimus | Capsule; Oral | Astellas | Labeling Revision |
| Prograf | tacrolimus | Injectable; Injection | Astellas | Labeling Revision |
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