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Strides received US FDA approval for Lamivudine and Stavudine

Strides Arcolab receives NDA approval from USFDA for Lamivudine and Stavudine under PEPFAR scheme. – Strides Arcolab Limited (Strides) announced that it has received tentative approval from the United States ? Food and Drug Administration for one new drug application (NDA) for fixed dose combination of Lamivudine and Stavudine Tablets 150 mg / 30 mg under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR).

FDA and CDC recommendations for consumers using peanut products

FDA and CDC have issued recommendations for US consumers using peanut butter products. – US consumers are urged to check FDA’s web site – www.fda.gov – to determine which products have been recalled and will be recalled in the coming days.

Update on FDA’s Investigation of Salmonella outbreak in US

US Food and Drug Administration (FDA) is conducting a very active and dynamic investigation into the source of the Salmonella Typhimurium outbreak in the country. – The Food and Drug Administration (FDA) is conducting a very active and dynamic investigation into the source of the Salmonella Typhimurium outbreak.

FDA will review Daiichi Sankyo, Lilly drug Prasugrel for heart attack

Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE: LLY) are co-developing prasugrel, an investigational oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd., as a potential treatment, initially for patients with acute coronary syndrome who are managed with PCI. – Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) confirmed that the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) will review prasugrel during an advisory committee hearing on February_3, 2009.

Diet Coke Plus violating US FDA food safety law

Diet Coke Plus violating US FDA food safety law. The US Food and Drug Administration (FDA) reviewed the label for Diet Coke Plus 20 FL OZ (1.25 PT) 591ml, and concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act. – The US Food and Drug Administration (FDA) reviewed the label for Diet Coke Plus 20 FL OZ (1.25 PT) 591ml. Based on the review, FDA concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

US FDA assessed melamine and melamine compounds in food

US FDA issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food. – The U.S. Food and Drug Administration (FDA) issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.

Trials supporting FDA approved drugs remained unpublished

Over half of all supporting trials determining efficacy for FDA-approved drugs with statistically significant results and larger sample sizes remained unpublished 5 years after approval. – Over half of all supporting trials for FDA-approved drugs remained unpublished 5 years after approval, says new research published in this week’s PLoS Medicine. The most important trials determining efficacy, and those with statistically significant results and larger sample sizes, are more likely to be published.

Health expert urges FDA to take action to reduce BPA exposure

US action to reduce BPA exposures may offer an effective intervention for improving health and reducing the burden of some of the most consequential human health problems. – Researchers found a significant relationship between urine concentrations of the environmental estrogen bisphenol A (BPA) and cardiovascular disease, type 2 diabetes and liver-enzyme abnormalities.

FDA should take steps to challenge bogus immunity claims

The US nonprofit nutrition watchdog urged the Food and Drug Administration (FDA) to crack down on that and other deceptive ?structure/function? claims increasingly appearing on food labels. – US Center for Science in the Public Interest (CSPI) urges FDA to crack down on food frauds saying that Kraft, General Mills, Dole, & others ripping off consumers with bogus immunity claims.

FDA to establish offices in China

U.S. Food and Drug Administration to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People’s Republic of China. – In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People’s Republic of China, pending authorization from the Chinese government.