From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 20 Jun 2008 05:34:29 -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: June 20, 2008 |
The following new items were added to the CDRH web pages on June 19, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Medical Devices; Technical Amendment. |  |  |
| Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Slides | |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 20 Jun 2008 09:57:31 -0500 (CDT)
Subject: CDER New 6/18 & 19/2008
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June 19, 2008
- Manual of Policies and Procedures (MaPP) 4151.6 "Drug Safety Newsletter"
- New and Generic Drug Approvals
- Agrylin (anagrelide hydrochloride) Capsules, Shire Development, Inc., Labeling Revision
- Buprenorphine Hydrochloride Tablets, Roxane Laboratories, Inc., Tentative Approval
- Byetta (exenatide synthetic) Injection, Amylin Pharmaceuticals, Inc., Labeling Revision
- Cetirizine Hydrochloride Syrup, Apotex Corp., Approval
- Cetirizine Hydrochloride Syrup, Perrigo Israel Pharmaceuticals, Ltd.., Approval
- Claritin (loratadine) Capsules, Schering-Plough HealthCare Products, Approval
- Hydromorphone Hydrochloride Injection, Hospira, Inc., Approval
- Metoprolol Tartrate Tablets, Ohm Laboratories, Inc., Approval
- Prilosec OTC (omeprazole magnesium) Delayed-Release Tablets, AstraZeneca LP, Package Change
- Ribavirin Tablets, Three Rivers Pharmaceuticals, LLC, Packager Addition
- Synercid (quinupristin and dalfopristin) I.V., King Pharmaceuticals, Inc., Labeling Revision
- Trandolapril Tablets, Glenmark Generics Inc., USA, Approval
- Trivaris (triamcinolone acetonide) Injectable Suspension, Allergan, Inc., Approval
- Office of Compliance
- Contact Information (updated)
- Immediate Office Staff (updated)
June 18, 2008
- Drugs@FDA Downloadable Data Files (updated)
- New and Generic Drug Approvals
- Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules, Eli Lilly and Co., Approval
- Mysoline (primidone) Tablets, Valeant Pharmaceuticals International, Manufacturing Change or Addition
- Pulmicort Flexhaler (budesonide) Inhalation Powder, AstraZeneca, Labeling Revision
- Requip XL (ropinirole) Extended-Release Tablets, GlaxoSmithKline, Approval
- Sodium Iodide I-123 Capsules, Syncor Pharmaceuticals, Inc., Labeling Revision
- Venlafaxine Hydrochloride Tablets, Caraco Pharmaceutical Laboratories, Ltd., Approval
- Venlafaxine Hydrochloride Tablets, Mylan Pharmaceuticals, Inc., Approval
- Venlafaxine Hydrochloride Tablets, Pliva Hrvatska, Approval
- Venlafaxine Hydrochloride Tablets, Sandoz, Inc., Approval
- Venlafaxine Hydrochloride Tablets, Zydus Pharmaceuticals USA, Inc., Approval
- Questions and Answers on Heparin Sodium Injection (Baxter) (updated)
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 20 Jun 2008 15:05:48 -0500 (CDT)
Subject: Drug Shortage: MVI Adult Injectable
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Drug Shortage: MVI Adult Injectable
Fri, 20 Jun 2008 13:05:00 -0500
Hospira information updated.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 20 Jun 2008 17:16:30 -0500 (CDT)
Subject: CDER New 6/20/2008
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June 20, 2008
- Drug Shortages:
- Fentanyl transdermal patch (updated)
- MVI Adult Injectable (updated)
- Electronic Common Technical Document (eCTD) (updated)
- New and Generic Drug Approvals
- Advil Cold & Sinus (ibuprofen and pseudoephedrine HCl) Tablets, Wyeth Consumer Healthcare, Labeling Revision
- Avodart (dutasteride) Soft Gelatin Capsule, GlaxoSmithKline, New or Modified Indication
- Cetirizine Hydrochloride Syrup, Ranbaxy Inc., Approval
- Junior Strength Advil (ibuprofen) Tablets, Wyeth Consumer Healthcare, Labeling Revision
- Lamivudine/Stavudine Tablets, Cipla Ltd., Tentative Approval
- Ramipril Capsules, Actavis Mid Atlantic, LLC, Approval
- Ramipril Capsules, Sandoz Inc., Approval
- Ramipril Capsules, Roxane Laboratories, Inc., Approval
- Ramipril Capsules, Invagen Pharmaceuticals, Inc., Approval
- Ramipril Capsules, Teva Pharmaceuticals USA, Approval
- Ramipril Capsules, Dr. Reddy's Laboratories, Ltd., Approval
- Office of Generic Drugs: May First-Time Generic Drug Approvals
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)
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