Drugs

FDA Gets Injunction Against Drug, Supplement Firms

A Colordao federal judge has granted a permanent injunction against EonNutra, CDSM, and HABW, manufacturers and distributors of unapproved drugs and dietary supplements, and their owner, Michael Floren, requiring the businesses to immediately cease operations until they comply with federal law. An FDA news release says Floren marketed products on many Web sites and in a Colorado Springs, CO, retail location.

The agency inspected Floren’s businesses, which shared a location, four times since 2012, the release says. Despite assurances from Floren that the deficiencies noted during the inspections would be corrected, it says, follow-up inspections found that he had repeatedly failed to make the necessary corrections.

FDA says it determined that the firms’ dietary supplements were misbranded and unapproved new drugs because they were being marketed with drug claims despite not being approved for any use. Some of the claims for Floren’s products included treating high cholesterol, hypertension, diabetes, depression, and muscle pain.

Agency investigators also found during the inspections that the businesses were manufacturing and distributing misbranded and adulterated dietary supplements. Numerous violations of current good manufacturing practice (cGMP) regulations for dietary supplements were found, including failing to establish specifications for dietary supplement components and failing to test or verify that components and finished products meet product specifications for identity, purity, strength, or composition.

The release says the dietary supplements are adulterated because the companies failed to follow cGMP regulations. Some of the supplements also are misbranded because the businesses failed to list on the products’ label the number of servings per container and the correct serving size per container. They also failed to list each ingredient contained in the dietary supplement and to identify the part of the plant each botanical dietary ingredient was derived from.

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