FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared a Mesa Biotech 510(k) for its Accula Flu A/Flu B test for use on the company’s polymerase chain reaction testing platform, which is designed for point-of-care infectious disease diagnosis. The test provides a qualitative result in about 30 minutes. It is indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs.

FDA has cleared an Empatica 510(k) for Embrace, a smart watch that monitors for seizures known as “grand mal” or “generalized tonic-clonic” seizures. Once detected, the watch sends an alert to summon a caregiver for help. The device measures multiple seizure indicators. It uses “electrodermal activity,” a signal used by stress researchers to quantify physiological changes related to sympathetic nervous system activity, also known as the “fight or flight” response.

DRUGS

FDA has approved a Novartis supplemental BLA for Cosentyx (secukinumab) to update its label to include moderate-to-severe scalp psoriasis. Expanded approval was based on data from a Phase 3 trial in scalp psoriasis patients where Cosentyx demonstrated superior efficacy compared to placebo, the company says. The human interleukin-17A inhibitor was originally approved in 2015 for treating adults with moderate-to-severe plaque psoriasis.

FDA has approved an Amag Pharmaceuticals supplemental NDA to broaden the existing label for Feraheme (ferumoxytol injection) beyond the current chronic kidney disease indication to include all eligible adult iron deficiency anemia patients who have intolerance to oral iron or have had unsatisfactory response to oral iron. Approval was based on data from two pivotal Phase 3 trials evaluating Feraheme versus iron sucrose or placebo in a broad population of patients with iron deficiency anemia. It also included data from a clinical safety trial comparing Feraheme to Injectafer (ferric carboxymaltose injection) in 2,000 adults.

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