Drugs

Court Dismisses Amiodarone Suit Against Sandoz

An Alabama federal court has granted Sandoz’ motion to dismiss a suit against it alleging that it failed to warn sufficiently about risks in use of amiodarone (a generic form of Wyeth’s Cordarone), off-label promotion, negligence, and failure to provide a Medication Guide to a man who died as a result of taking the drug off-label for atrial fibrillation. The court agreed with Sandoz that the charges against the company were preempted by federal law.

The court also recognized that the company had no obligation to provide a Medication Guide to patients, but only to the dispensing pharmacist. And it said that the state’s learned intermediary doctrine bars the estate’s failure-to-warn claim, even if it were not preempted. It also held that the plaintiff’s off-labeling marketing claims lacked the detail and specificity required by the rules of evidence.

The plaintiff was permitted to amend the complaint, in part, to restate the off-label promotion claim since the court said that it is not clear that the plaintiff cannot state such a claim against the defendant.

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

Read more

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