Drugs

Allergan NDA for Rosacea Topical Drug Accepted for Review

FDA has accepted for review an Allergan NDA for oxymetazoline HCl cream 1.0% for treating persistent facial erythema (redness) associated with rosacea in adults. The company expects a user fee target date in first half of 2017.

Oxymetazoline is a sympathomimetic agonist that is selective for the a1A-adrenoceptor over other a1-adrenoceptors and non-selective for the a2-adrenoceptors, Allergan says. “As such, oxymetazoline is a potent vasoconstrictor of the cutaneous microvasculature.”

The submission was based on data collected from two Phase 3 pivotal clinical trials involving a 29-day treatment duration and a one-year open label clinical trial. They enrolled male and female patients 18 years of age and older with moderate to severe persistent facial erythema associated with rosacea.

“While the pathophysiology of rosacea remains largely unknown, it is thought to be a chronic, inflammatory and vascular disorder,” the company says. It is not curable, and it usually requires long-term treatment to alleviate symptoms and delay or prevent disease progression.

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