Drugs

Roxane Secures First Generic Xyrem Approval

FDA says it has approved a Roxane Laboratories ANDA for the first generic version of Jazz Pharmaceuticals’ Xyrem (sodium oxybate) oral solution for treating cataplexy and excessive daytime sleepiness in patients with narcolepsy. The approval requires Roxane to implement strict safety controls on prescribing and dispensing under a Risk Evaluation and Mitigation Strategy (REMS), an agency notice says. “The use of Xyrem has been associated with serious side effects including seizures, trouble breathing, changes in alertness, coma, and death,” it says. “Additionally, the active ingredient in Xyrem (and in the newly approved generic) is sodium oxybate. Sodium oxybate is the sodium salt of gamma hydroxybutyrate (GHB). GHB has not been approved for any medical use and has the potential for abuse, such as in cases of sexual assault.”

FDA says that after “extensive review and consideration” it waived the requirement that the brand drug (Xyrem) and generic drugs utilize a single, shared system for the REMS with ETASU. “The agency has determined that the generic sodium oxybate REMS has the same ETASU as the Xyrem REMS and operationalizes those elements in a comparable manner to the approved Xyrem REMS.” Specifically, under both the Xyrem REMS and the generic sodium oxybate REMS, sodium oxybate can be prescribed only by a certified prescriber, and dispensed only to an enrolled patient by a certified pharmacy, FDA says. The drug is not available in retail pharmacies, and only a certified pharmacy that ships directly to patients can dispense sodium oxybate, it adds.

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