Drugs

Wave Miami Distributing Unapproved New Drug: FDA

FDA says that a Wave Miami Web site and Facebook page for its Lipro Dietary Capsule are promoting an unapproved new drug that also is misbranded. A 1/13 Warning Letter says the agency confirmed through laboratory analysis that the Lipro Dietary Capsule contains undeclared tadalafil (branded Cialis), used to treat erectile dysfunction. “This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels,” the letter says.

FDA says it continues to recommend that Wave Miami recall the product from the market.

The letter notes that although the Lipro product is marketed as a dietary supplement, under the Federal Food, Drug, and Cosmetic Act, a dietary supplement may not include an article that is approved as a new drug unless it was marketed as a dietary supplement or food before its approval as a drug. Tadalafil does not qualify in that way, it says.

Wave Miami was told to take prompt action to correct the violations and to respond with the current status of its corrective actions and the specific steps taken to correct the violations, with documentation of each step and a timetable for completion.

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