What's New on the FDA Drugs Site
December 11, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Safety Communication: FDA reporting mental health drug ziprasidone (Geodon) associated with rare but potentially fatal skin reactions
- FDA Drug Shortages: Updated
- Cefazolin Injection (Currently in Shortage)
- Clindamycin Phosphate (Cleocin) Injection (Currently in Shortage)
- Memantine Hydrochloride (Namenda) XR Capsules (Currently in Shortage)
- National Drug Code Directory
- Pediatric Exclusivity Statistics (updated)
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
- Presentation: CDER New Drug Review: 2014 Update (PDF - 1.3MB)
- Presentation: Update From the Office of Surveillance and Epidemiology (PDF - 780KB)
New and Generic Drug Approvals
December 10, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Advair Hfa | fluticasone propionate; salmeterol xinafoate | Aerosol, Metered;Inhalation | Glaxo Grp Ltd | Labeling Revision |
| Flovent Hfa | fluticasone propionate | Aerosol, Metered;Inhalation | Glaxo Grp Ltd | Labeling Revision |
| Geodon | ziprasidone hydrochloride | Capsule;Oral | Pfizer | Labeling Revision |
| Geodon | ziprasidone mesylate | Injectable;Intramuscular | Pfizer | Labeling Revision |
| Geodon | ziprasidone hydrochloride | Suspension;Oral | Pfizer Inc | Labeling Revision |
| Zoledronic Acid | zoledronic acid | Injectable;Iv (Infusion) | Acs Dobfar Info Sa | Labeling Revision |
December 9, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Belviq | lorcaserin hydrochloride | Tablet;Oral | Eisai Inc | Labeling Revision |
| Extraneal | icodextrin | Solution;Intraperitoneal | Baxter Hlthcare | Labeling Revision |
| Onfi | clobazam | Tablet;Oral | Lundbeck Llc | Labeling Revision |
| Onfi | clobazam | Suspension;Oral | Lundbeck Llc | Labeling Revision |
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