Drugs

FDA OKs Botox Expanded Indication

FDA has approved Allergan’s Botox (onabotulinumtoxinA) for treating lower limb spasticity in adult patients to decrease the severity of increased stiffness in ankle and toe muscles. The drug was first approved in 2010 for treating upper limb spasticity (ULS), or increased muscle stiffness in the elbow, wrist and fingers. Additional approval was granted last year to expand its use for treating adults with ULS to include the addition of two thumb muscles.

The latest approval, according to the company, was based on a large, international development program that evaluated the safety and efficacy of Botox compared to placebo in more than 400 patients with lower limb spasticity following stroke. “Statistically significant improvements were observed in the two co-primary endpoints of average change from baseline in the improvement of muscle tone measured by the Modified Ashworth Scale ankle score and the clinical benefit for patients as assessed by the Clinical Global Impression of Change by Physician at weeks four and six (p<0.05),” Allergan 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