What's New on the FDA Drugs Site
March 16, 2015
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Safety Communications (Spanish)
- La FDA actualiza la etiqueta del medicamento para dejar de fumar Chantix (vareniclina), para incluir la posible interacción con el alcohol, un riesgo poco común de sufrir convulsiones, y los estudios de efectos secundarios en el estado de ánimo, la conducta o el pensamiento
- La FDA evalúa riesgo de derrame, ataque cardiaco y muerte por usar productos con testosterona aprobados por la FDA
- La FDA exige el uso de etiquetas de advertencia para prohibir que los pacientes compartan las plumas de insulina reutilizables
- National Drug Code Directory
- Office of Scientific Investigations Metrics Overview (updated)
New and Generic Drug Approvals
March 13, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Depacon | valproate sodium | Injectable;Injection | Abbvie | Labeling Revision |
| Depakene | valproic acid | Syrup;Oral | Abbvie | Labeling Revision |
| Depakote | divalproex sodium | Tablet, Delayed Release;Oral | Abbvie | Labeling Revision |
| Depakote | divalproex sodium | Capsule, Delayed Rel Pellets;Oral | Abbvie | Labeling Revision |
| Depakote Er | divalproex sodium | Tablet, Extended Release;Oral | Abbvie | Labeling Revision |
| Humalog | insulin lispro recombinant | Injectable;Injection | Lilly | Labeling Revision |
| Humalog Kwikpen | insulin lispro recombinant | Injectable;Injection | Lilly | Labeling Revision |
| Humalog Pen | insulin lispro recombinant | Injectable;Injection | Lilly | Labeling Revision |
| Kepivance | palifermin | Injectable; Injection | Biovitrum Ab | Labeling Revision |
| Nexterone | amiodarone hydrochloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
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Tuesday, March 17, 2015
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