Drugs

FDA Approves 2 Upsher-Smith sNDAs for Migraine Drug

FDA has approved two Upsher-Smith Laboratories supplemental NDAs for Qudexy XR (topiramate) Extended-Release Capsules for use in preventing migraine headache in adults and adolescents 12 years of age and older. Topiramate is the active ingredient in Janssen Pharmaceuticals’ Topamax (topiramate) and is the molecule that neurologists prescribe most frequently for the prevention of migraines, according to the company.

Qudexy XR has been engineered to deliver a level pharmacokinetic profile and was shown to reduce the peak-to-trough fluctuation of topiramate plasma concentrations that are associated with immediate-release topiramate, the company says. Upsher-Smith has also agreed to address post-marketing requirements with a study to evaluate the efficacy and safety of Qudexy XR for preventing migraine in pediatric patients aged 6-11.

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