From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jul 2008 05:44:15 -0500 (CDT)
Subject: CDER New 7/29/2008
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July 29, 2008
- FDA reminds health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. MedWatch Safety Information
- New and Generic Drug Approvals
- Anaprox (naproxen sodium) Tablets, Hoffmann-La Roche, Inc., Labeling Revision
- Anaprox DS (naproxen sodium) Tablets, Hoffmann-La Roche, Inc., Labeling Revision
- EC-Naprosyn (naproxen) Delayed-Release Tablets, Hoffmann-La Roche, Inc., Labeling Revision
- Lopressor HCT (hydrochlorothiazide and metoprolol tartrate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Naprosyn (naproxen) Tablets, Hoffmann-La Roche, Inc., Labeling Revision
- Naprosyn (naproxen) Oral Suspension, Hoffmann-La Roche, Inc., Labeling Revision
- Pamidronate Disodium Injection, PharmaForce, Inc., Approval
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jul 2008 08:07:17 -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: July 30, 2008 |
The following new items were added to the CDRH web pages on July 29, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Gastroenterology and Urology Devices Panel Advisory Meeting, June 25, 2008 - Agenda, Draft Roster, Final Roster, Briefing, Questions, Transcript |  |
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jul 2008 08:18:25 -0500 (CDT)
Subject: FDA Warning Letters Update
You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jul 2008 09:52:11 -0500 (CDT)
Subject: CFSAN Constituent Update
* U.S. Food and Drug Administration * CONSTITUENT UPDATE Constituent Updates are also available on the web at http://www.cfsan.fda.gov/~dms/cfsupdat.html.
* Center for Food Safety and Applied Nutrition *
July 30, 2008
FDA Seeks Comments on Newly-Enacted Section 301(ll) of the Food, Drug, and Cosmetic Act Which Prohibits the Interstate Shipment of Certain Foods
The U.S. Food and Drug Administration recently published a notice in the Federal Register requesting data, information, and comments relevant to the agency's implementation of Section 912 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). We are issuing this Constituent Update to alert you to this request and to encourage you to submit relevant data, information, and comments. You may submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may also submit electronic comments to www.regulations.gov. All comments are to be submitted by October 27, 2008.
Section 912 of FDAAA establishes section 301(ll) in the Food, Drug, and Cosmetic Act, which prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added. Section 301(ll) also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public. Foods that may be affected by the provisions of section 301(ll) include human food, including infant formula, medical foods, and dietary supplements, and their ingredients; food contact substances, including most food packaging; and animal feed, including pet food and feed ingredients. We are seeking comments about the impact of section 301(ll) on food in all its forms, including food ingredients, categories of food, and finished food products.
We believe that section 301(ll) presents a number of questions of statutory interpretation for our consideration. So that we may better understand the impact of various interpretations of section 301(ll), we are requesting comments on possible approaches to implementation and the impact of those approaches. We have included in the Federal Register notice a series of questions to guide your responses to our request for comments.
If you have questions about this request for comments, you may contact Catherine Copp at Catherine.copp@fda.hhs.gov.
Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jul 2008 10:12:53 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Guidances Update
You are subscribed to CBER's Guidances for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jul 2008 13:04:02 -0500 (CDT)
Subject: Federal Agents Seize more than $24 Million in Unapproved New Drugs
Federal Agents Seize more than $24 Million in Unapproved New Drugs
Wed, 30 Jul 2008 12:17:00 -0500
Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jul 2008 15:35:05 -0500 (CDT)
Subject: CDER New 7/30/2008
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July 30, 2008
- Drugs@FDA Downloadable Data Files (updated)
- New and Generic Drug Approvals
- Baraclude (entecavir) Oral Solution, Bristol-Myers Squibb Co., Efficacy Supplement with Clinical Data to Support
- Baraclude (entecavir) Tablets, Bristol-Myers Squibb Co., Efficacy Supplement with Clinical Data to Support
- Claritin (loratadine) Syrup, Schering-Plough HealthCare Products, Inc., Labeling Revision
- Claritin (loratadine) Syrup, Schering-Plough HealthCare Products, Inc., Package Change
- Claritin Hives Relief (loratadine) Syrup, Schering-Plough HealthCare Products, Inc., Labeling Revision
- Claritin Hives Relief (loratadine) Syrup, Schering-Plough HealthCare Products, Inc., Package Change
- Ketorolac Tromethamine Ophthalmic Solution, Alcon, Inc., Tentative Approval
- Lamisil AT (terbinafine hydrochloride) Topical Solution, Novartis Consumer Health, Inc., Package Change
- Lamisil AT (terbinafine hydrochloride) Topical Spray, Novartis Consumer Health, Inc., Package Change
- Navstel (hypromellose, dextrose and glutathione) Ophthalmic Solution, Alcon, Inc., Approval
- Nisoldipine Extended-Release Tablets, Mylan Pharmaceuticals, Inc., Approval
- Provocholine (methacholine chloride) Inhalation Solution, Methapharm, Inc., Labeling Revision
- Vicoprofen (hydrocodone bitartrate and ibuprofen) Tablets, Abbott Laboratories, Labeling Revision
Update: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jul 2008 20:04:37 -0500 (CDT)
Subject: FDA Extends Consumer Warning on Serrano Peppers from Mexico
FDA Extends Consumer Warning on Serrano Peppers from Mexico
Wed, 30 Jul 2008 18:38:00 -0500
Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States.
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