---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Tue, Aug 26, 2014 at 7:39 AM
Subject: CDER New August 26, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Tue, Aug 26, 2014 at 7:39 AM
Subject: CDER New August 26, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
August 25, 2014
- FDA Drug Shortages: New and Updated
- Famotidine Injection (New - Currently in Shortage)
- Sincalide (Kinevac) Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Manual of Policies and Procedures (MAPP) NDAs and BLAs: Communication to Applicants of Planned Review Timelines (PDF - 155KB)
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
New and Generic Drug Approvals
August 22, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Ampyra | dalfampridine | Tablet, Extended Release;Oral | Acorda | Manufacturing Change or Addition |
| Dextrose 10% and Sodium Chloride 0.11% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 10% and Sodium Chloride 0.33% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 10% In Plastic Container | dextrose | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 2.5% and Sodium Chloride 0.11% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 2.5% and Sodium Chloride 0.2% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 2.5% and Sodium Chloride 0.33% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 2.5% and Sodium Chloride 0.45% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 2.5% and Sodium Chloride 0.9% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 2.5% In Half-Strength Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 2.5% In Plastic Container | dextrose | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 4% In Modified Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 5% In Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 5% In Plastic Container | dextrose | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 5% In Sodium Chloride 0.45% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Dextrose 7.7% In Plastic Container | dextrose | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Fexofenadine Hydrochloride | fexofenadine hydrochloride | Tablet;Oral | Aurolife Pharma Llc | Tentative Approval |
| Gilenya | fingolimod | Capsule;Oral | Novartis | Manufacturing Change or Addition |
| Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container | heparin sodium | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Heparin Sodium 12,500 Units In Sodium Chloride 0.45% In Plastic Container | heparin sodium | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Container | heparin sodium | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container | heparin sodium | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container | heparin sodium | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Container | heparin sodium | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Lidocaine Hydrochloride 0.2% and Dextrose 5% In Plastic Container | lidocaine hydrochloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Lidocaine Hydrochloride 0.4% and Dextrose 5% In Plastic Container | lidocaine hydrochloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Lidocaine Hydrochloride 0.8% and Dextrose 5% In Plastic Container | lidocaine hydrochloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Midazolam Hydrochloride | midazolam hydrochloride | Injectable;Injection | Bd Rx | Approval |
| Minocycline Hydrochloride | minocycline hydrochloride | Tablet, Extended Release;Oral | Mylan Pharms Inc | Approval |
| Minocycline Hydrochloride | minocycline hydrochloride | Tablet, Extended Release;Oral | Mylan Pharms Inc | Tentative Approval |
| Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Sodium Chloride 0.9% In Plastic Container | potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Sodium Chloride 0.9% In Plastic Container | potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Sodium Chloride 0.9% In Plastic Container | potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Sodium Chloride 0.9% In Plastic Container | potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Sodium Chloride 0.9% In Plastic Container | potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Sodium Chloride 0.9% In Plastic Container | potassium chloride; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Prinivil | lisinopril | Tablet;Oral | Merck | Manufacturing Change or Addition |
| Rivastigmine Tartrate | rivastigmine tartrate | Capsule;Oral | Macleods Pharms Ltd | Approval |
| Theophylline 0.04% and Dextrose 5% In Plastic Container | theophylline | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Theophylline 0.08% and Dextrose 5% In Plastic Container | theophylline | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Theophylline 0.16% and Dextrose 5% In Plastic Container | theophylline | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Theophylline 0.2% and Dextrose 5% In Plastic Container | theophylline | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Theophylline 0.32% and Dextrose 5% In Plastic Container | theophylline | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Theophylline 0.4% and Dextrose 5% In Plastic Container | theophylline | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Tobramycin | tobramycin | Solution;Inhalation, Nebulizer | Pulmoflow Inc | Tentative Approval |
| Triumeq | abacavir sulfate;dolutegravir;lamivudine | Tablet;Fixed-Dose, Combinatiion | Viiv Hlthcare | Approval |
| Uceris | budesonide | Tablet, Extended Release;Oral | Santarus Inc | Manufacturing Change or Addition |
| Zorvolex | diclofenac | Capsule;Oral | Iroko Pharms Llc | Efficacy Supplement with Clinical Data to Support |
| This email was sent to iammejtm@gmail.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
Jeremy Tobias Matthews
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