Drugs

Appeals Court Backs FDA’s Sameness Interpretation

The U.S. Court of Appeals for the D.C. Circuit has upheld a lower court’s decision for FDA that a “clinically superior drug is not the same as a drug that is otherwise the same.” The appeals court reaffirmed that FDA acted correctly in determining that Avadel CNS Pharmaceuticals’ Lumryz (sodium oxybate) is a different drug than Jazz Pharmaceuticals’ Xywav (sodium oxybate) because of a different dosing regimen, and thus correctly approved the Avadel product for marketing before Xywav finished its orphan drug marketing exclusivity.

Jazz had argued that FDA incorrectly concluded that Lumryz and Xywav are not the same drug, even though they have the same active moiety, but not the same dosing regimen. It also contended that the agency’s determination that Lumryz was clinically superior to Xywav was arbitrary and capricious because it did not comply with internal dispute resolution procedures and because the findings were inconsistent with the scientific literature.

In agreeing with the lower court’s decision, the appeals court supported FDA’s finding that Lumryz’s extended-release formulation demonstrated a clinical superiority because it is a major improvement in patient convenience — eliminating a middle-of-the-night dose, and justifying its separate exclusivity period.

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