U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Updates: 1

From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 14 May 2008 06:23:37 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: May 14, 2008

The following new items were added to the CDRH web pages on May 13, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Transcripts

---

Updates: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 14 May 2008 09:12:13 -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.

---

Updates: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 14 May 2008 14:06:23 -0500 (CDT)
Subject: Enforcement Report for May 14, 2008

Enforcement Report for May 14, 2008
Wed, 14 May 2008 12:01:00 -0500

Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

---

Updates: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 14 May 2008 15:20:07 -0500 (CDT)
Subject: CDER New 5/14/2008

May 14, 2008

• Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book
• Drugs@FDA Downloadable Data Files (updated)
• FDA releases a Follow-up to the November 14, 2007, Communication about the Ongoing Safety Review of Cefepime (marketed as Maxipime).
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• New and Generic Drug Approvals
  • Cyclobenzaprine Hydrochloride Tablets, Ranbaxy, Inc., Approval
  • Definity (perflutren lipid microsphere) Injection, Lantheus Medical Imaging, Labeling Revision
  • Flumazenil Injection, Akorn-Strides, LLC., Approval
  • Haldol (haloperidol decanoate) Injection, Ortho McNeil Pharmaceutical, Labeling Revision
  • Haldol (haloperidol lactate) Injection, Ortho McNeil Pharmaceutical, Labeling Revision
  • Lariam (mefloquine hydrochloride) Tablets, Hoffmann-La Roche, Inc., Labeling Revision
  • Lidocaine Hydrochloride and Epinephrine Injection, Hospira, Inc., Approval
  • Probenecid and Colchicine Tablets, Concord Laboratories, Inc., Approval
  • Ramipril Capsules, Lupin Pharmaceuticals, Inc., Tentative Approval
  • Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
  • Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, New or Modified Indication
  • Valium (diazepam) Tablets, Roche Products, Labeling Revision

---

Updates: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 14 May 2008 17:05:19 -0500 (CDT)
Subject: Manufacturer Removes Remaining Stocks of Trasylol

Manufacturer Removes Remaining Stocks of Trasylol
Wed, 14 May 2008 16:53:00 -0500

Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician’s stock. The FDA will work with Bayer to ensure a smooth and complete process.

---

Updates: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 14 May 2008 17:05:23 -0500 (CDT)
Subject: Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7)

Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7)
Wed, 14 May 2008 16:30:00 -0500

Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs.

---

Updates: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 14 May 2008 20:07:05 -0500 (CDT)
Subject: MedWatch - Trasylol [aprotinin injection] to be removed from all hospital pharmacies, available only under limited use agreement access

Trasylol (aprotinin injection)
Audience: Cardiovascular healthcare professionals, pharmacists, hospital surgical service managers

Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses.

Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.

Read the complete MedWatch safety summary, including links to the updated drug information page and the FDA news statement, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Trasylol

---

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420