---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, Aug 25, 2014 at 7:57 AM
Subject: CDER New August 25, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, Aug 25, 2014 at 7:57 AM
Subject: CDER New August 25, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
August 22, 2014
- Medication Guides (Updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- FDA Drug Shortages: New and Updated
- Atropine Sulfate Injection (Currently in Shortage)
- Magnesium Sulfate Injection (Currently in Shortage)
- Papaverine Hydrochloride Injection (Currently in Shortage)
- Trace Elements (Currently in Shortage)
New and Generic Drug Approvals
August 21, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Benazepril Hydrochloride and Hydrochlorothiazide | benazepril hydrochloride;hydrochlorothiazide | Tablet;Oral | Apotex Inc | Approval |
| Duodote | atropine; pralidoxime chloride | Injectable;Intramuscular | Meridian Medcl | Manufacturing Change or Addition |
| Elidel | pimecrolimus | Cream;Topical | Valeant Bermuda | Manufacturing Change or Addition |
| Eliquis | apixaban | Tablet;Oral | Bristol Myers Squibb | Efficacy Supplement with Clinical Data to Support |
| Kazano | alogliptin benzoate; metformin hydrochloride | Tablet;Oral | Takeda Pharms Usa | Manufacturing Change or Addition |
| Levocetirizine Dihydrochloride | levocetirizine dihydrochloride | Solution;Oral | Apotex Inc | Approval |
| Potassium Chloride | potassium chloride | Tablet, Extended Release;Oral | Mylan Pharms Inc | Approval |
| Pralidoxime Chloride | pralidoxime chloride | Injectable;Injection | Meridian Medcl Techn | Manufacturing Change or Addition |
| Prepopik | citric acid; magnesium oxide; sodium picosulfate | For Solution;Oral | Ferring Pharms As | Manufacturing Change or Addition |
| Retin-A Micro | tretinoin | Gel;Topical | Valeant Intl | Manufacturing Change or Addition |
| Retin-A-Micro | tretinoin | Gel;Topical | Valeant Intl | Manufacturing Change or Addition |
| Revatio | sildenafil citrate | Solution;Intravenous | Pfizer | Manufacturing Change or Addition |
| Rifampin | rifampin | Injectable;Injection | Fresenius Kabi Usa | Approval |
| Sandostatin Lar | octreotide acetate | Injectable;Injection | Novartis | Manufacturing Change or Addition |
| Zoledronic Acid | zoledronic acid | Injectable;Injection | Akorn Inc | Approval |
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Jeremy Tobias Matthews
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