---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Jun 25, 2014 at 7:01 AM
Subject: CDER New June 25, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Jun 25, 2014 at 7:01 AM
Subject: CDER New June 25, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
June 24, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Safety Communication: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required
- FDA Drug Safety Podcast: FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)
New and Generic Drug Approvals
June 23, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Bromfenac Sodium | bromfenac sodium | Solution/Drops;Ophthalmic | Apotex Inc | Approval |
| Enoxaparin Sodium (Preservative Free) | enoxaparin sodium | Injectable;Subcutaneous | Teva | Approval |
| Lisdexamfetamine Dimesylate | lisdexamfetamine dimesylate | Capsule;Oral | Roxane | Tentative Approval |
| Metro I.V. In Plastic Container | metronidazole | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Morphine Sulfate | morphine sulfate | Solution;Im-Iv | Bd Rx | Manufacturing Change or Addition |
| Naphcon-A | naphazoline hydrochloride; pheniramine maleate | Solution/Drops;Ophthalmic | Alcon | Manufacturing Change or Addition |
| Omniscan | gadodiamide | Injectable;Injection | Ge Healthcare | Manufacturing Change or Addition |
| Pancreaze | pancrelipase (amylase;lipase;protease) | Capsule, Delayed Release;Oral | Janssen Pharms | Manufacturing Change or Addition |
| Triesence | triamcinolone acetonide | Injectable;Intravitreal | Alcon | Manufacturing Change or Addition |
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Jeremy Tobias Matthews
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