Canadian Health Network's Healthlink for February 14, 2008
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You are subscribed to Alcohol and Drug Abuse Trends for Public Health - Seattle & King County.
The latest report of the King County Alcohol and Drug Abuse Trends Update with data through the first half of 2007 is now available online at http://www.metrokc.gov/health/subabuse
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You are subscribed to Press Releases for Public Health - Seattle & King County.
The agenda for the February 21, 2008 King County Board of Health meeting is now available at http://www.metrokc.gov/health/news/08021401.htm
Key topics on the agenda:
An update on continuity and emergency preparedness planning
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You are subscribed to HIV/AIDS Statistics for Public Health - Seattle & King County.
The Monthly HIV/AIDS Epidemiology Report for King County through 1/31/08 is now updated online at http://www.metrokc.gov/health/apu/epi/epistats.htm
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You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.
Please do not reply to this message.
On February 14, 2008, FDA granted approval for a generic formulation of Zidovudine Tablets, 300 mg., manufactured by Matrix Laboratories, Inc. of Hyderabad, India. The application was reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR). However, because patent protections for the reference product, Retrovir Tablets,300 mg, made by GlaxoSmithKline have expired, this generic product can be marketed in the United States, as well as being available for purchase under the PEPFAR program.
A list of all FDA approved generic antiretroviral drugs for the treatment of HIV is available on the web at http://www.fda.gov/oashi/aids/viralsgeneric.html
Zidovudine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI) indicated for the treatment of HIV in combination with other antiviral medications.
As with all FDA-approved generics, this product must meet all of FDA's manufacturing quality, and clinical safety and effectiveness standards.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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Summit Import Corporation Issues Allergy Alert on Undeclared Sulfites in Oriental Mascot Brand Sweetened Sliced Coconut (Feb. 1)
Thu, 14 Feb 2008 11:45:00 -0600
Summit Import Corp. is recalling "Oriental Mascot Brand Sweetened Sliced Coconut" because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites may run the risk of serious or life-threatening allergic reactions if they consume this product. The product comes in an uncoded 4 oz plastic container. The recalled "Oriental Mascot Brand Sweetened Sliced Coconut" was distributed in New York State.
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Enforcement Report for February 13, 2008
Thu, 14 Feb 2008 05:46:00 -0600
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.
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You are subscribed to Workshops and Conferences for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
The Eleventh US-Japan Cellular and Gene Therapy Conference on Tissue Engineering - February 28, 2008
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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420