---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Tue, Jun 10, 2014 at 6:41 AM
Subject: CDER New June 10, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Tue, Jun 10, 2014 at 6:41 AM
Subject: CDER New June 10, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
June 9, 2014
- Draft Guidance for Industry: Providing Submissions in Electronic Format — Postmarketing Safety Reports (PDF - 117KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
New and Generic Drug Approvals
June 8, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Diprivan | propofol | Injectable;Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Duragesic-100 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Duragesic-12 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Duragesic-25 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Duragesic-50 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Duragesic-75 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Manufacturing Change or Addition |
June 6, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Bunavail | buprenorphine;naloxone | Film;Buccal | Biodelivery Sciences Inc | Approval |
| Cefepime and Dextrose In Duplex Container | cefepime hydrochloride | Injectable;Injection | B Braun | Labeling Revision |
| Clinolipid 20% | olive oil; soybean oil | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Jublia | efinaconazole | Solution;Topical | Dow Pharm | Approval |
| Nascobal | cyanocobalamin | Spray, Metered;Nasal | Par Pharm | Labeling Revision |
| Rosuvastatin Calcium | rosuvastatin calcium | Tablet;Oral | Apotex Corp | Tentative Approval |
| Sodium Chloride 3% In Plastic Container | sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Sodium Chloride 5% In Plastic Container | sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Trileptal | oxcarbazepine | Tablet;Oral | Novartis | Labeling Revision |
| Trileptal | oxcarbazepine | Suspension;Oral | Novartis | Labeling Revision |
| Zithromax | azithromycin | For Suspension;Oral | Pfizer | Labeling Revision |
| Zithromax | azithromycin | For Suspension;Oral | Pfizer | Labeling Revision |
| Zithromax | azithromycin | Tablet;Oral | Pfizer | Labeling Revision |
| Zithromax | azithromycin | Tablet;Oral | Pfizer | Labeling Revision |
| Zithromax | azithromycin | Injectable;Injection | Pfizer | Labeling Revision |
| Zithromax | azithromycin | Tablet;Oral | Pfizer | Labeling Revision |
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Jeremy Tobias Matthews
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