Drugs

Jazz Pharma Sues FDA Over Competitor Approval

Jazz Pharmaceuticals has filed a 6/22 lawsuit in the DC federal court against FDA, seeking to reverse the 5/1 approval of Avadel CNS Pharmaceuticals’ Lumryz, a sodium oxybate drug product citing Jazz’s Xyrem as the reference-listed drug, indicated for treating cataplexy or excessive daytime sleepiness in adult patients with narcolepsy.

In the complaint, Jazz alleges that FDA “acted outside its authority under the Orphan Drug Act when, despite the orphan drug exclusivity (ODE) protecting Jazz’s low-sodium oxybate product Xywav, FDA approved the Lumryz NDA and granted Lumryz ODE based on FDA’s finding that Lumryz makes a major contribution to patient care and is therefore clinically superior to Xywav and Xyrem.” Additionally, Jazz says FDA “failed to follow its own regulations, failed to follow established agency policy without providing a reasoned explanation for the departure, reversed prior decisions by its own staff and experts without a reasoned explanation, and disregarded the relevant scientific literature and data.”

Jazz also says it believes that FDA’s Lumryz decision could compromise patient safety and undermine appropriate patient care. “Jazz further believes that the proper functioning of the Orphan Drug Act is critical to ensuring the ongoing development of products to treat rare diseases by providing meaningful incentives for companies to continue to develop innovative treatments for patients with rare diseases,” the company says.

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