Drugs

Virtus Pharma Sues FDA Over Unapproved Drugs Guidance

Virtus Pharmaceuticals has filed suit against FDA in middle Florida federal court seeking an order barring enforcement action against the company’s unapproved and allegedly grandfathered potassium chloride drug products. According to the company, after being marketed without an approved NDA for decades, two of Virtus’s competitors gained approval for their potassium chloride products. In June, FDA told Virtus to stop distributing the unapproved products.

In its complaint, Virtus claims that FDA’s guidance on Unapproved Drug Products is arbitrary and capricious. It is “particularly arbitrary in its grant of effective market exclusivity for a company that obtains NDA approval for a product like (potassium chloride) that other companies have been marketing without approval for many decades.” The company also argues that the guidance has the force of law by seeking to “impose substantive rights and limitations on the regulated public without subjecting its attempt to make law to the notice-and-comment limitation inherent” under the Administrative Procedures Act.

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