U.S. Food and Drug Administration News

Information on Nutrition and Medications

Federal Register: Medical Devices; Medical Device Reporting; Baseline Reports; Confirmation of Effective Date

Published in September 16th, 2008

Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health

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The FDA is confirming the effective date of October 27, 2008, for the final rule that appeared in the Federal Register of June 13, 2008 (73 FR 33692). The direct final rule amends the MDR regulation by removing the requirement for baseline reports.

Mylan receives FDA approval for generic version of Risperdal

Published in September 16th, 2008

Posted by Pharmaceutical News Feed in Drugs and Food Information, Pharmaceutical Industry News

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Mylan Inc today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Risperidone Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg.

FDA warns Ranbaxy Labs and issues import alert

Published in September 16th, 2008

Posted by Pharmaceutical News Feed in Drugs and Food Information, Pharmaceutical Industry News

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The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy’s Dewas and Paonta Sahib plants in India.

Eating Pistachios May Help Reduce Cardiovascular Risk

Published in September 16th, 2008

Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News

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In a small, randomized study, intake of pistachios was effective in reducing cardiovascular risk factors.
Medscape Medical News

Gastric Bypass Surgery May Be Effective for Weight Loss in Most Patients

Published in September 16th, 2008

Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News

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In a prospective cohort study, gastric bypass surgery was an effective way for most patients to lose weight, but poor results were associated with diabetes and larger gastric pouch size.
Medscape Medical News

Bazedoxifene Reduces Non-Vertebral Fracture Risk in Postmenopausal Women

Published in September 16th, 2008

Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News

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Three-year results with the investigational agent bazedoxifene (Viviant; Wyeth), a selective estrogen receptor modulator (SERM), show that it reduces the incidence of non-vertebral fractures as well as vertebral fractures in postmenopausal women.
Reuters Health Information

Rulemaking History for OTC Sunscreen Drug Products: Time and Extent Applications (updated)

Published in September 16th, 2008

Posted by FDA Center for Drug Evaluation and Research - What's New in Drug Evaluation and Research

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Rulemaking History for OTC Sunscreen Drug Products: Time and Extent Applications (updated)

Meetings of the Nonprescription Drugs Advisory Committee (NDAC) (updated)

Published in September 16th, 2008

Posted by FDA Center for Drug Evaluation and Research - What's New in Drug Evaluation and Research

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Meetings of the Nonprescription Drugs Advisory Committee (NDAC) (updated)

Statin Use Suboptimal Among Elderly Atherosclerosis Patients

Published in September 16th, 2008

Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News

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Statin use by elderly patients with atherosclerosis is suboptimal despite improvements in the last 10 years, according to a study conducted in Canada.
Reuters Health Information