From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 8 Jul 2008 05:49:04 -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 8, 2008 |
The following new items were added to the CDRH web pages on July 7, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | 510(k) Final Decisions - June 2008 |  |
| Gastroenterology and Urology Devices Panel Advisory Meeting, June 25, 2008 - Agenda, Draft Roster, Final Roster, Briefing, Questions | |
| Hematology and Pathology Devices Panel Advisory Meeting, July 18, 2008 - Other | |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 8 Jul 2008 08:24:30 -0500 (CDT)
Subject: Drug Information Update- Authorized Generics
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
On September 27, 2007, the President signed into law the Food and Drug Administration Amendments Act (FDAAA) (Public Law 110-85). Among other things, FDAAA added new subsection (t) to section 505 of the Federal Food, Drug, and Cosmetic Act (the Act). Section 505(t) is titled “Database For Authorized Generic Drugs,” and requires that FDA publish a complete list on its Internet site of all authorized generic drugs, including (1) the drug trade name, (2) the brand company manufacturer, and (3) the date the authorized generic drug entered the market. The agency is required to update the list quarterly. Section 505(t)(2) of the Act requires the list to contain authorized generic drugs included in an annual report submitted to the agency after January 1, 1999.
An “authorized generic drug” is a listed drug as defined in § 314.3 that has been approved under subsection 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with either labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark that differs from that of the listed drug.
For FDA listing of authorized generics, please visit: http://www.fda.gov/cder/ogd/AG_Listing.htm
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 8 Jul 2008 09:02:36 -0500 (CDT)
Subject: FDA Approves New Genetic Test for Patients with Breast Cancer
FDA Approves New Genetic Test for Patients with Breast Cancer
Tue, 08 Jul 2008 08:31:00 -0500
The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab).
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 8 Jul 2008 10:04:22 -0500 (CDT)
Subject: Drug Information Update- Fluoroquinolone Antimicrobial Drugs
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients. The addition of a boxed warning and a Medication Guide would strengthen the existing warning information already included in the prescribing information for fluoroquinolone drugs.
Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug.
Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria.
For more information, visit: http://www.fda.gov/cder/drug/infopage/fluoroquinolones/default.htm
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 8 Jul 2008 13:03:39 -0500 (CDT)
Subject: FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs
FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs
Tue, 08 Jul 2008 12:51:00 -0500
The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 8 Jul 2008 10:54:01 -0500 (CDT)
Subject: MedWatch - Fluoroquinolones: Boxed Warning to be added for risk of tendon rupture and tendinitis
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FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.
This risk of tendinitis and tendon rupture is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria.
Read the complete MedWatch 2008 Safety Summary, including a link to the 'Information for Healthcare Professionals' page, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fluoroquinolone
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