Drugs

Correct ‘Misleading’ AbbVie Study Description: Ali

Ali Pharmaceutical Manufacturing, a subsidiary of American Laboratories, is asking FDA to require AbbVie to correct what Ali says is the misbranding of an investigational product in a thyroid study. The Ali petition says AbbVie is not using Ali’s Armour Thyroid in a study “to assess the safety and efficacy of oral Armour Thyroid compared to synthetic for the treatment of primary hypothyroidism in adult patients.”

The petition says the AbbVie investigational product is a biologic that contains a novel active pharmaceutical ingredient that is different from the active ingredient in Armour Thyroid and thus is not Armour Thyroid.

Ali also asks that FDA take other appropriate actions to ensure that patients already enrolled and considering enrolling in the study, study investigators, and study staff are accurately

informed about the identity of the investigational product.

The petition says there is urgency in the matter since the study started on 4/26 with an intended enrollment of 2,800 patients and is currently enrolling patients at 107 locations in the U.S. “The risks of this investigational product, which has a very limited treatment history, may be different from the risks of a product that has been safely used by more than one million Americans over decades,” Ali says.

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