FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved a Medtronic PMA supplement for a new arm indication for the Guardian Sensor 3 glucose monitor that will enable patients to wear the sensor on the upper arm. The company says this is the only sensor FDA approved to control automated insulin delivery via a hybrid closed loop system —- the MiniMed 670G system. The device features the company’s most advanced SmartGuard algorithm, which helps to increase “time-in-range by automatically adjusting basal insulin delivery every five minutes based on real-time data,” it says.

DRUGS

FDA has approved a Scilex Pharmaceuticals NDA for ZTlido (lidocaine topical system) 1.8%, indicated for relieving pain associated with post-herpetic neuralgia (post-shingles pain). The anhydrous topical system is based on a novel technology that is designed to achieve superior adhesion and drug delivery efficiency, according to the company.

FDA has approved Eli Lilly’s Verzenio (abemaciclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for treating postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. This is the third indication for Verzenio within five months; in 9/2017, Verzenio became the first cyclin-dependent kinase 4 & 6 inhibitor approved in combination and as a single agent in metastatic breast cancer.

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