Drugs

Genesis Ultra Gold is Unapproved Weight Loss Drug: FDA

FDA says its review of Web sites and social media pages maintained by Genesis Nutrition Ultra Slim, doing business as Genesis Ultra Slim, Doral, FL, indicates that the firm markets its Genesis Ultra Slim Gold product intended for weight loss. A just-released 8/6 Warning Letter says the agency confirmed through laboratory analysis that the product contains undeclared sibutramine and phenolphthalein.

Sibutramine is the active ingredient in the withdrawn weight loss drug Meridia, FDA says, and phenolphthalein is a chemical that is not an active ingredient in any approved drug in the U.S., and studies have indicated that it presents a cancer-causing risk.

Genesis markets Ultra Slim Gold as a dietary supplement, the Warning Letter says, but dietary supplements may not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public. FDA says it received the IND application for Meridia on 12/24/1985.

Genesis Ultra Slim Gold is an unapproved new drug, the letter says, and also is misbranded because its labeling fails to contain adequate directions for use and is false and misleading.

Genesis was told to respond with a list of steps it has taken to address the violations and prevent their recurrence, with copies of related documentation and a schedule for completing the corrections.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome