Drugs

Exclude Liraglutide from Compounding: Novo Nordisk

Novo Nordisk has petitioned FDA to exclude its liraglutide from the agency’s list of bulk drug substances that may be used by outsourcing facilities in compounding. Liraglutide is a GLP-1 agonist and is the active ingredient in the company’s diabetes drugs Victoza and Xultophy and weight-loss therapy Saxenda.

In the petition, Novo Nordisk contends that liraglutide does not meet the standard and criteria to be included in the bulk drug substance listing for which there is a “clinical need” to compound. “The physical and chemical characterization of liraglutide weighs against a finding of clinical need,” the petition says. “There is abundant scientific evidence showing that even small changes in the manufacturing process of liraglutide can substantially affect its chemical and physical stability, as well as its impurity profile.”

Additionally, the petition states that safety issues raised by the use of compounded liraglutide “weigh against a finding of clinical need. The impurity profiles and, in particular, the evidence of fibril formation in the unapproved liraglutide products raise significant immunogenicity risks and pose serious threats to patients’ health.”

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