What's New on the FDA Drugs Site
March 24, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Current Drug Shortages Index (updated)
- Guidance for Industry: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway (PDF - 170KB)
- National Drug Code Directory
New and Generic Drug Approvals
March 22, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Auvi-Q | epinephrine | Injectable;Intramuscular, Subcutaneous | Sanofi Aventis Us | Manufacturing Change or Addition |
March 21, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adenosine | adenosine | Injectable;Injection | Strides Inc | Approval |
| Ethiodol | ethiodized oil | Oil;Intralymphatic, Intrauterine | Guerbet | Labeling Revision |
| Heparin Sodium | heparin sodium | Injectable;Injection | Fresenius Kabi Usa | Labeling Revision |
| Heparin Sodium | heparin sodium | Injectable;Injection | Fresenius Kabi Usa | Labeling Revision |
| Heparin Sodium In Plastic Container | heparin sodium | Injectable;Injection | Fresenius Kabi Usa | Labeling Revision |
| Heparin Sodium Preservative Free | heparin sodium | Injectable;Injection | Fresenius Kabi Usa | Labeling Revision |
| Otezla | apremilast | Tablet; Oral | Celgene | Approval |
| Striant | testosterone | Tablet, Extended Release;Buccal | Actient Pharms | Labeling Revision |
| Synagis | palivizumab | Vial | Medimmune | Labeling Revision |
| Thyrogen | thyrotropin alfa | Injectable;Injection | Genzyme | Efficacy Supplement with Clinical Data to Support |
| Tussionex Pennkinetic | chlorpheniramine polistirex; hydrocodone polistirex | Suspension, Extended Release;Oral | Ucb Inc | Manufacturing Change or Addition |
| Xolair | omalizumab | Vial | Genentech | Efficacy Supplement with Clinical Data to Support |
| Zecuity | sumatriptan succinate | System;Iontophoresis | Nupathe | Labeling Revision |
| This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
