---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, Jun 13, 2014 at 7:04 AM
Subject: CDER New June 13, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, Jun 13, 2014 at 7:04 AM
Subject: CDER New June 13, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
June 12, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology Reviews (updated)
New and Generic Drug Approvals
June 11, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adempas | riociguat | Tablet;Oral | Bayer Hlthcare | Supplement |
| Caverject Impulse | alprostadil | Injectable;Injection | Pharmacia and Upjohn | Labeling Revision |
| Colgate Total | sodium fluoride; triclosan | Paste;Dental | Colgate Palmolive | Labeling Revision |
| Doxazosin | doxazosin mesylate | Tablet;Oral | Accord Hlthcare Inc | Approval |
| Duloxetine | duloxetine hydrochloride | Capsule, Delayed Release;Oral | Apotex Inc | Approval |
| Duloxetine Hydrochloride | duloxetine hydrochloride | Capsule, Delayed Rel Pellets;Oral | Breckenridge Pharm | Approval |
| Erlotinib Hydrochloride | erlotinib hydrochloride | Tablet; Oral | Mylan Pharma | Approval |
| Gadavist | gadobutrol | Solution;Intravenous | Bayer Hlthcare | Efficacy Supplement with Clinical Data to Support |
| Magnevist | gadopentetate dimeglumine | Injectable;Injection | Bayer Hlthcare | Labeling Revision |
| Magnevist | gadopentetate dimeglumine | Injectable;Injection | Bayer Hlthcare | Labeling Revision |
| Nicorette | nicotine polacrilex | Gum, Chewing;Buccal | Glaxosmithkline | Labeling Revision |
| Nicorette | nicotine polacrilex | Gum, Chewing;Buccal | Glaxosmithkline | Labeling Revision |
| Nicorette (Mint) | nicotine polacrilex | Gum, Chewing;Buccal | Glaxosmithkline | Labeling Revision |
| Nicorette (Mint) | nicotine polacrilex | Gum, Chewing;Buccal | Glaxosmithkline | Labeling Revision |
| Noxafil | posaconazole | Tablet, Delayed Release;Oral | Merck Sharp Dohme | Labeling Revision |
| Prandimet | metformin hydrochloride; repaglinide | Tablet;Oral | Novo Nordisk Inc | Manufacturing Change or Addition |
| Sutent | sunitinib malate | Capsule;Oral | Cppi Cv | Labeling Revision |
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Jeremy Tobias Matthews
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