Friday, July 25, 2008

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

Update: 1

From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Jul 2008 08:03:49 -0500 (CDT)
Subject: Current Drug Shortage: Proglycem (diazoxide) oral suspension

FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

Current Drug Shortage: Proglycem (diazoxide) oral suspension
Thu, 24 Jul 2008 07:40:00 -0500

Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652

Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Jul 2008 09:47:32 -0500 (CDT)
Subject: FDA Data Standards Update - CBER SPL Docket Memo & Rescheduling of SPL R4 Biologic Drug Product Training Session

Greetings,

The FDA Data Standards Council's SPL web page (http://www.fda.gov/oc/datacouncil/spl.html) was updated Thursday, July 24, 2008, to include the following information:

SPL - Content of Labeling (CBER) Docket Memo: http://www.fda.gov/oc/datacouncil/spl_docket_memo_cber_col.pdf

Notification of rescheduled SPL Release Four Biologic Drug Products Training Session (August 14, 2008) http://www.fda.gov/oc/datacouncil/spl_rel_four_training_sessions_july_08.html.

Lonnie Smith

Project Manager

Structured Product Labeling Team

Medical Informatics Staff &

FDA Data Standards Council

Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Jul 2008 16:03:12 -0500 (CDT)
Subject: Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product

Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product
Thu, 24 Jul 2008 15:50:00 -0500

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient.

Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Jul 2008 16:03:14 -0500 (CDT)
Subject: Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product (July 24)

Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product (July 24)
Thu, 24 Jul 2008 15:50:00 -0500

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient.

Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Jul 2008 16:12:37 -0500 (CDT)
Subject: CDER New 7/24/2008

FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

CDERnew Logo

July 24, 2008

Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Jul 2008 17:02:50 -0500 (CDT)
Subject: Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18)

Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18)
Thu, 24 Jul 2008 16:36:00 -0500

Sau-Sea foods, Inc, of Water Mill NY is recalling all tubs of SMOKED SALMON Spread with the sell by dates as follows: 072308, 082708, 092408, 1 12508, 03 1309. People who have an allergy or severe sensitivity to egg run the risk of serious or life threatening allergic reaction if they consume these products.

Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Jul 2008 14:50:40 -0500 (CDT)
Subject: MedWatch - Abacavir/Ziagen: Association between HLA allele and severe hypersensitivity reactions identified

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Abacavir (marketed as Ziagen) and Abacavir-containing Medications
Audience: Infectious disease and medical genetics healthcare professionals
FDA informed healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. FDA reviewed data from two studies that support a recommendation for pre-therapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects. Genetic tests for HLA-B*5701 are available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Development of clinically suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701.

Read the complete MedWatch 2008 Safety Summary, including a link to the Information for Healthcare Professionals document, at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Abacavir

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