---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, Aug 29, 2014 at 9:01 AM
Subject: CDER New August 29, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, Aug 29, 2014 at 9:01 AM
Subject: CDER New August 29, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
August 28, 2014
- FDA Drug Shortages: New and Updated
- Clonidine HCL Injection (Duraclon) (New - Currently in Shortage)
- Irrigation Solutions (New - Currently in Shortage)
- Drug Info Rounds Video Traveling with Prescription Medications
- CDER Key Officials List (PDF - 125KB) (updated)
- Manual of Policies and Procedures (MAPP) Communicating Drug Approval Information (PDF - 331KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
New and Generic Drug Approvals
August 27, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Clonazepam | clonazepam | Tablet;Oral | Sun Pharm Inds Inc | Approval |
| Elelyso | taliglucerase alfa | Powder;Iv (Infusion) | Pfizer | Efficacy Supplement with Clinical Data to Support |
| Elelyso | taliglucerase alfa | Powder;Iv (Infusion) | Pfizer | Labeling Revision |
| Ella | ulipristal acetate | Tablet;Oral | Lab Hra Pharma | Labeling Revision |
| Megestrol Acetate | megestrol acetate | Suspension;Oral | Twi Pharms Inc | Approval |
| Metoprolol Tartrate | metoprolol tartrate | Injectable;Injection | Gland Pharma Ltd | Approval |
| Nephramine 5.4% | amino acids | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Olopatadine Hydrochloride | olopatadine hydrochloride | Solution;Ophthalmic | Watson Labs Inc | Tentative Approval |
| Phoslyra | calcium acetate | Solution;Oral | Fresenius Medcl | Manufacturing Change or Addition |
| Vimovo | esomeprazole magnesium; naproxen | Tablet, Delayed Release;Oral | Horizon Pharma | Manufacturing Change or Addition |
| Xopenex Hfa | levalbuterol tartrate | Aerosol, Metered;Inhalation | Sunovion | Manufacturing Change or Addition |
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Jeremy Tobias Matthews
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