---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, Aug 22, 2014 at 11:06 AM
Subject: CDER New August 22, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, Aug 22, 2014 at 11:06 AM
Subject: CDER New August 22, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
August 21, 2014
- Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Paragraph IV Patent Certifications (updated)
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
New and Generic Drug Approvals
August 20, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adenoscan | adenosine | Injectable;Injection | Astellas | Labeling Revision |
| Arnuity Ellipta | fluticasone furoate | Powder;Inhalation | Glaxosmithkline | Approval |
| Clinolipid 20% | olive oil; soybean oil | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Depacon | valproate sodium | Injectable;Injection | Abbvie | Labeling Revision |
| Depakene | valproic acid | Capsule;Oral | Abbvie | Labeling Revision |
| Depakene | valproic acid | Syrup;Oral | Abbvie | Labeling Revision |
| Depakote | divalproex sodium | Tablet, Delayed Release;Oral | Abbvie | Labeling Revision |
| Depakote | divalproex sodium | Capsule, Delayed Rel Pellets;Oral | Abbvie | Labeling Revision |
| Depakote Er | divalproex sodium | Tablet, Extended Release;Oral | Abbvie | Labeling Revision |
| Fulyzaq | crofelemer | Tablet, Delayed Release;Oral | Salix Pharms | Manufacturing Change or Addition |
| Hydroxyzine Hydrochloride | hydroxyzine hydrochloride | Tablet;Oral | Emcure Pharms Usa | Approval |
| Intelence | etravirine | Tablet;Oral | Janssen R and D | Labeling Revision |
| Levonorgestrel | levonorgestrel | Tablet;Oral | Perrigo R and D | Approval |
| Polyethylene Glycol 3350;Potassium Chloride;Sodium Bicarbonate;Sodium Chloride and Bisacodyl | polyethylene glycol 3350;potassium chloride;sodium bicarbonate;sodium chloride;bisacodyl | Solution;Oral and Tablet;Delayed Release | Novel Labs Inc | Approval |
| Pristiq | desvenlafaxine succinate | Tablet, Extended Release;Oral | Wyeth Pharms Inc | Approval |
| Radiogardase (Prussian Blue) | ferric hexacyanoferrate(ii) | Capsule;Oral | Heyl Chemisch | Labeling Revision |
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Jeremy Tobias Matthews
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