What's New on the FDA Drugs Site
March 12, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms
- Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level (PDF - 241KB)
- National Drug Code Directory (updated)
New and Generic Drug Approvals
March 11, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Ceftriaxone and Dextrose In Duplex Container | ceftriaxone sodium | Injectable; Injection | B Braun | Labeling Revision |
| Fibricor | fenofibric acid | Tablet; Oral | Ar Holding Co Inc | Labeling Revision |
| Humalog | insulin lispro recombinant | Injectable; Injection | Lilly | Labeling Revision |
| Humalog Kwikpen | insulin lispro recombinant | Injectable; Injection | Lilly | Labeling Revision |
| Humalog Mix 50/50 | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Labeling Revision |
| Humalog Mix 50/50 Kwikpen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Labeling Revision |
| Humalog Mix 50/50 Pen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Labeling Revision |
| Humalog Mix 75/25 | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Labeling Revision |
| Humalog Mix 75/25 Kwikpen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Labeling Revision |
| Humalog Mix 75/25 Pen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Labeling Revision |
| Humalog Pen | insulin lispro recombinant | Injectable; Injection | Lilly | Labeling Revision |
| Namenda | memantine hydrochloride | Tablet; Oral | Forest Labs | Manufacturing Change or Addition |
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