Drugs

FDA OKs New Allergan Acne Treatment

FDA has approved Allergan’s Aczone (dapsone) gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older. According to the company, the gel treats both inflammatory and non-inflammatory acne in a once-a-day application with a new pump delivery system. Allergan says 4,340 acne patients were studied in two identically designed 12-week trials in which Aczone’s safety and efficacy were assessed. FDA approved the product based on co-primary endpoints of the Global Acne Assessment Score and lesion counts (20 to 50 inflammatory and 30 to 100 non-inflammatory lesions at baseline), the company says. Allergan reports study results at week 12 showed that inflammatory lesions were reduced by 15.8 lesions vs 13.9 lesions with vehicle and non-inflammatory lesions were reduced by 20.7 lesions vs 18.0 lesions with vehicle (39.4%). It adds that out of 2161 patients who used Aczone Gel, 7.5%, 1.1% experienced mild application-site dryness vs 1.0% with vehicle and 0.9% experienced pruritus vs 0.5% with vehicle.

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