Drugs

FDA Consent Decree with MyNicNaxs

A Florida federal judge has approved a consent decree of permanent injunction sought by FDA against MyNicNaxs, Deltona, FL, and company owner Chevonne Torres and officer Michael Banner. The agency says the company distributed weight loss and sexual enhancement products, marketed as dietary supplements, directly to consumers through two Web sites. Some of the products tested positive for undeclared active pharmaceutical ingredients, FDA says.

A complaint filed with the consent decree says that FDA tests showed some of the MyNicNaxs products contained ingredients such as sildenafil, sibutramine, and phenolphthalein. The complaint says the company’s products are considered drugs under the Federal Food, Drug, and Cosmetic Act because they are intended to cure, treat, or prevent disease. It also says the drugs are misbranded because their labeling is false and misleading in that it does not declare certain active pharmaceutical ingredients, the labeling fails to bear adequate directions for use, and/or the drugs are dangerous to health when used as recommended in the labeling.

The permanent injunction requires the defendants to stop directly or indirectly distributing any unapproved new drugs or misbranded drugs. MyNicNaxs is prohibited from receiving, manufacturing, holding, or distributing any drugs or dietary supplements until they receive written notification from FDA that they appear to be in compliance with the decree, the Federal Food, Drug, and Cosmetic Act and its regulations, and that they may resume operations.

FDA had issued a 2015 Warning Letter to the company after discovering that it continued to sell unapproved new drugs and misbranded drugs.

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

Read more

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