Drugs

Ortho Dermatologics Gain Psoriasis Lotion Approval

FDA has approved an Ortho Dermatologics NDA for Duobrii (halobetasol propionate and tazarotene) lotion, 0.01%/0.045%, indicated for the topical treatment of plaque psoriasis in adults. The company says that when used separately to treat psoriasis, halobetasol propionate’s (a corticosteroid) use duration is limited by FDA labeling constraints and tazarotene’s (a retinoid) use can be limited due to tolerability concerns. By combining the two in a once-daily moisturizing lotion, the Duobrii formulation “ensures uniform distribution, allowing for simultaneous contact with the skin surface,” the company says.

Approval was based on date from a Phase 3 study that demonstrated the lotion was consistently more effective than its individual agents and a vehicle in achieving treatment success and reducing psoriasis signs of erythema, plaque elevation, and scaling at the target lesion, the company says. “In addition, a post-hoc analysis of the data, in which the vehicle effect was removed, showed that the efficacy of Duobrii was superior to the aggregated results of the individual agents, supporting the synergy of the two ingredients when combined in one lotion formulation,” it 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