Drugs

Leo Pharma Gets Updated Prescribing Info for Enstilar

FDA has approved a Leo Pharma supplemental NDA for updated prescribing information for Enstilar (calcipotriene and betamethasone dipropionate) Foam to include data on long-term use in adults with plaque psoriasis. The corticosteroid is approved for the topical treatment of plaque psoriasis in patients 12 years and older.

The submission was based on data from the Phase 3 PSO-LONG clinical trial that evaluated the long-term use of Enstilar Foam in adult patients who achieved treatment success, defined as Physician Global Assessment score of “clear” or “almost clear” with at least a two-grade improvement from baseline, after an initial four-week treatment with the product. “Those treated long-term twice-weekly with Enstilar Foam had a longer time to first loss of response and fewer losses of response than those using vehicle foam,” the company says.

Safety was evaluated based on effects on calcium homeostasis and on hypothalamic-pituitary-adrenal (HPA) axis with long-term use of twice-weekly calcipotriene and betamethasone dipropionate foam, Leo says. “No clinically relevant effects on calcium metabolism or the HPA axis were observed,” it adds.

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