Drugs

Court Backs FDA in Somatuline Depot Case

The DC federal court says FDA correctly determined that Ipsen Biopharmaceuticals’ Somatuline Depot should be regulated as a drug rather than as a biologic. Ipsen had argued that the FDA decision was arbitrary, capricious, an abuse of discretion, and contrary to law.

Ruling on cross motions for summary judgment filed by Ipsen and FDA, the court granted FDA’s motion to dismiss the suit and denied Ipsen’s motion.

Somatuline Depot is described as an extended-release dosing of lanreotide acetate, a molecule that mimics the naturally occurring hormone somatostatin. The drug is indicated to treat patients suffering from acromegaly, a rare hormone disorder.

In 12/2021, FDA approved an InvaGen NDA for a lanreotide acetate injection to treat acromegaly and gastroenteropancreatic neuroendocrine tumors. The InvaGen product was approved as a drug under the 505(b)(2) pathway that allowed the company to cite Ipsen’s clinical data for Somatuline Depot. InvaGen joined FDA as a defendant in the case.

“FDA’s conclusion that Somatuline Depot is a drug, rather than a biological product, was not contrary to the relevant statute or the regulations,” the court said. “Further, the agency’s factual determinations were well-reasoned, consistent with the evidence, and addressed Ipsen’s objections.”

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