Drugs

FDA Approves Differin OTC Acne Drug

FDA has approved Galderma Laboratories’ Differin Gel 0.1% (adapalene), a once-daily topical gel for over-the-counter treatment of acne in people age 12 and older. An agency statement says Differin Gel is the first retinoid to be made available OTC for treating acne. FDA also says the gel contains the first new active ingredient for acne treatment for OTC use since the 1980s. Differin Gel was originally approved in 1996 as a prescription product for treating acne vulgaris in patients age 12 and older.

The statement says that the drug’s safety and efficacy were initially established based on five clinical trials in people with mild to moderate acne. To support approval for the OTC switch, data accrued from 1996 to 2016 on post-marketing safety, data from consumer studies, and data from a maximal use trial were submitted. Results from the consumer studies, FDA says, showed that consumers can understand the information on the OTC label, appropriately select whether the product is right for them, and use the product appropriately. The maximal use trial reportedly demonstrated that absorption is limited, thus supporting safe OTC use of the product.

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