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Move From Daily To Weekly Welsh Assembly Government Swine Flu Reports, Wales
On 2 July, based on scientific advice, the UK moved to a new "treatment" phase in our response to the current swine flu pandemic.
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Drug Manufacturer Receives Fast Track Designation From FDA
Pharmaceutical firm Biogen Idec announced that the American drug watchdog the Food and Drug Administration (FDA) has granted Fast Track designation for its multiple sclerosis (MS) drug PEGylated interferon beta-1a (BIIB017).
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Food And Drug Administration Moves Towards Greater Openness
The Food and Drug Administration is taking steps towards greater openness. The Associated Press reports that FDA Commissioner Margaret Hamburg "announced Tuesday she has created a task force to make recommendations on how the agency can release more information in such areas as drug evaluation and enforcement matters. She wants a report in six months." Deputy Commissioner Joshua Sharfstein will head the task force, which will represent all of the FDA"s major divisions as well as its law enforcement branch. It will hold two public meetings with the first on June 24. "The FDA has long operated under strict confidentiality rules," the AP reports, and in opening up information, one sensitive issue will be what to do with unpublished clinical trial data from drug manufacturers. Despite such concerns, "Hamburg said she believes the need for secrecy may have been taken too far, and is harming the FDA"s credibility within the medical community and among consumers" (Alonso-Zaldivar, 6/2).
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FDA Approval For Cetirizine Hydrochloride Tablets (OTC) ANDA - Hay Fever And Other Respiratory Allergies

Taro Pharmaceutical Industries Ltd. reported that it has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for cetirizine hydrochloride tablets (OTC), 5 mg and 10 mg ("Cetirizine Tablets"). The product will be marketed by Taro"s U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc. Taro"s Cetirizine Tablets are bioequivalent to McNeil Consumer Healthcare"s Zyrtec® Allergy Tablets, 5 mg and 10 mg and Zyrtec® Hives Relief Tablets, 5 mg and 10 mg. Taro previously received approval for cetirizine hydrochloride oral solution in April 2008. Cetirizine Tablets are a nonprescription drug approved for the temporary relief of symptoms due to hay fever or other respiratory allergies (sneezing; runny nose; itchy, watery eyes; itchy throat or nose) in adults and children 2 years of age and older. Cetirizine Tablets are also approved for the relief of itching due to hives in adults and children 6 years of age and older. According to industry s, annual U.S. sales of this product are approximately $350 million. Taro is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products. Taro Pharmaceutical Industries Ltd


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