Drugs

FDA Approves VESIcare Pediatric Bladder Indication

FDA has approved Astellas Pharma’s VESIcare LS (solifenacin succinate) oral suspension to treat neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children age two and older. VESIcare tablets were approved in 2004 to treat overactive bladder in adults age 18 and older.

An agency statement says it is the first FDA-approved treatment for NDO patients as young as age two. It also notes that while the current standard of care for many such patients requires dosing up to three times daily, VESIcare LS is dosed only once a day.

Efficacy for the indication was established in two clinical trials with a total of 95 pediatric NDO patients ages two to 17, FDA says. The drug’s most common side effects are constipation, dry mouth, and urinary tract infection.

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