FDA Approves New Cholesterol-Lowering Drug

The U.S. Food and Drug Administration approved the 4 milligram maximum dose of Livalo (pitavastatin), a drug intended to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.

Like other statins, Livalo is intended for patients when diet and exercise fail to lower their cholesterol levels. Statins improve elevated blood cholesterol levels primarily by inhibiting a liver enzyme called HMG Co-A reductase, thus reducing the liver's ability to make cholesterol.

"Elevated or abnormal cholesterol levels are associated with an increased risk for heart disease and stroke," said Eric C. Colman, M.D., deputy director, Division of Metabolism and Endocrinology Products, in the FDA's Center for Drug Evaluation and Research. "Today's approval offers patients and their health care professionals another alternative way to treat high cholesterol."

Livalo was approved on the basis of five clinical trials comparing its efficacy and safety to that of three currently marketed statins.

The most frequently reported adverse reactions from taking Livalo were muscle pain, back pain, joint pain and constipation.

Livalo is manufactured by Kowa Pharmaceuticals America Inc. of Montgomery, Ala.

Source : www.medicalnewstoday.com

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FDA Approves New Cholesterol-Lowering Drug

The U.S. Food and Drug Administration today approved the 4 milligram maximum dose of Livalo (pitavastatin), a drug intended to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.

Like other statins, Livalo is intended for patients when diet and exercise fail to lower their cholesterol levels. Statins improve elevated blood cholesterol levels primarily by inhibiting a liver enzyme called HMG Co-A reductase, thus reducing the liver's ability to make cholesterol.

"Elevated or abnormal cholesterol levels are associated with an increased risk for heart disease and stroke," said Eric C. Colman, M.D., deputy director, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. “Today’s approval offers patients and their health care professionals another alternative way to treat high cholesterol.”

Livalo was approved on the basis of five clinical trials comparing its efficacy and safety to that of three currently marketed statins.

The most frequently reported adverse reactions from taking Livalo were muscle pain, back pain, joint pain and constipation.

Livalo is manufactured by Kowa Pharmaceuticals America Inc. of Montgomery, Ala.

Source : www.fda.gov

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Improper Labeling—Is Cheerios A Food or A Drug?

General Mills was just issued a Warning Letter by the U.S. Food and Drug Administration (FDA) for illegally marketing what Millennium Medical Information Services, Inc described as it’s new “drug”: Cheerios® Toasted Whole Grain Oat Cereal (Cheerios®).

The Cheerios® box reviewed by the FDA included the following statements:

1) “you can Lower Your Cholesterol 4% in 6 weeks”
2) “Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is … clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol.”

Millennium Medical Information explained that the FDA’s Warning Letter to General Mills is a reminder that both the broad nature of labeling as well as the broad definition for the word “drug” under the Federal Food, Drug, and Cosmetic Act (the Act) can result in unintended consequences from what appear to be so-called “innocuous product claims and that the letter highlights the problems that can occur when marketing food and drugs in the United States. When formulating marketing pieces that include product/drug claims, marketers and their agents should consider the expansive nature of the definition of “labeling” under the Act and the implication of a misbranding claim, said Millennium Medical Information.

The question remains, said Millennium Medical Information, “Are Cheerios® a food or a drug?”

According to the Act, a “drug” includes “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals … ” [21 U.S.C. section 321(g)(1)(B)]. The Cheerios® label’s claims, the FDA said, “that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia and also claims that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and “bad” (LDL) cholesterol.” The claims actually serve to present the breakfast cereal as a drug. The FDA letter can be accessed here: www.fda.gov/foi/warning_letters/s7188c.htm

Because Cheerios® “is not generally recognized, among experts … as safe and effective for use … suggested in the labeling ….” said the FDA, it qualifies as a “new drug” under the Act [21 U.S.C. section 321(P)(1)]. This means the cereal giant will have to seek out agency approval of a new drug application before the “new drug” can be introduced into interstate commerce [21 U.S.C. section 355(a)], said Millennium Medical Information, citing the FDA.

The FDA views Cheerios® as a “drug” because of how its maker described the cereal on the label. The agency also reviewed the product’s claims against regulatory authority governing health claims in food substances. Specifically, the FDA refers to the permissible soluble fiber health claim and the requirements in the applicable regulations and concluded that General Foods failed to conform to the specific requirements of the soluble fiber health claim concerning the degree of risk reduction for coronary heart disease to diets including foods eligible make that claim and also found that the cereal maker misbranded Cheerios® by including unauthorized health claims in its labeling, which appeared on its Website, not its box.

Source : www.newsinferno.com

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