---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Aug 27, 2014 at 7:13 AM
Subject: CDER New August 27, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Aug 27, 2014 at 7:13 AM
Subject: CDER New August 27, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
August 26, 2014
- Draft Guidance: Controlled Correspondence Related to Generic Drug Development (PDF - 113KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- New web-based learning course - "Human Drug Establishment Registration and Drug Listing Compliance"
New and Generic Drug Approvals
August 25, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Bacitracin | bacitracin | Injectable;Injection | Xellia Pharms Aps | Approval |
| Buspirone Hydrochloride | buspirone hydrochloride | Tablet;Oral | Strides Arcolab Ltd | Approval |
| Diabeta | glyburide | Tablet;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Faslodex | fulvestrant | Injectable;Intramuscular | Astrazeneca | Manufacturing Change or Addition |
| Invega Sustenna | paliperidone palmitate | Suspension, Extended Release;Intramuscular | Janssen Pharms | Manufacturing Change or Addition |
| Kabiven and Perikabiven | amino acids;electrolytes;dextrose;lipid | Injectable;Injection | Fresenius Kabi | Approval |
| Membraneblue | trypan blue | Solution;Ophthalmic | Dorc | Manufacturing Change or Addition |
| Oxacillin Sodium | oxacillin sodium | Injectable;Injection | Agila Speclts | Approval |
| Tafinlar | dabrafenib mesylate | Capsule;Oral | Glaxosmithkline | Manufacturing Change or Addition |
| Tricor | fenofibrate | Tablet;Oral | Abbvie | Manufacturing Change or Addition |
| Visionblue | trypan blue | Solution;Ophthalmic | Dorc | Manufacturing Change or Addition |
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Jeremy Tobias Matthews
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