Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 8 May 2008 05:20:16 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: May 8, 2008 |
The following new items were added to the CDRH web pages on May 7, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Summary Information for: Thoratec HeartMate II® Left Ventricular Assist System (LVAS) |  |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 8 May 2008 10:13:27 -0500 (CDT)
Subject: CDER New 5/7/2008
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May 7, 2008
- Drugs@FDA Downloadable Data Files (updated)
- New and Generic Drug Approvals
- Advair Diskus 100/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen
- Advair Diskus 250/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen
- Advair Diskus 500/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen
- Argatroban Injection, Encysive Pharmaceuticals, Inc., Efficacy Supplement with Clinical Data to Support
- Brevital Sodium (methohexital sodium) Injection, JHP Pharmaceuticals, LLC, Labeling Revision
- Bumetanide Injection, Baxter Healthcare Corp., Approval
- Cardiolite (Technetium Tc99m Sestamibi Kit) Injection, Bristol Myers Squibb, Patient Population Altered
- Humalog Mix 50/50 (insulin lispro protamine [rDNA origin] and insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
- Janumet (sitagliptin phosphate and metformin hydrochloride) Tablets, Merck & Co., Inc., Manufacturing Change or Addition
- Levaquin (levofloxacin) Tablets, Ortho-McNeil-Janssen Pharmaceutical, Inc., Patient Population Altered
- Levaquin (levofloxacin) Injection, Ortho-McNeil-Janssen Pharmaceutical, Inc., Patient Population Altered
- Levaquin in Dextrose 5% in Plastic Container (levofloxacin) Injection, Ortho-McNeil-Janssen Pharmaceutical, Inc., Patient Population Altered
- Levaquin (levofloxacin) Oral Solution, Ortho-McNeil-Janssen Pharmaceutical, Inc., Patient Population Altered
- Ropinirole Hydrochloride Tablets, Mylan Pharmaceuticals Inc., Approval
- Ropinirole Hydrochloride Tablets, Teva Pharmaceuticals, Approval
- Ropinirole Hydrochloride Tablets, Roxane Laboratories, Inc., Approval
- Ropinirole Hydrochloride Tablets, Par Pharmaceutical, Inc., Approval
- Sensipar (cinacalcet hydrochloride) Tablets, Amgen, Inc., Labeling Revision
- Vancocin Hydrochloride in Plastic Container (vancomycin hydrochloride) Injection, Baxter Healthcare Corp., Labeling Revision
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