FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved an Endomagnetics Inc. PMA for the Magtrace and Sentimag Magnetic Localization System, a device for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The device uses magnetic detection during sentinel lymph node biopsy procedures to identify specific (sentinel) lymph nodes for surgical removal, an agency release says.

FDA has cleared an Adherium 510(k) for its Hailie sensor and its use with Teva’s ProAir HFA, and GlaxoSmithKline’s Ventolin HFA and Flovent HFA asthma inhalers. The device attaches to a patient’s asthma medication inhaler to monitor and promote adherence as part of a self-management plan. The sensor tracks medication use and reminds users when it is time to take doses. It also captures usage history to better understand patterns in their asthma. Previously, the device was cleared for use with AstraZeneca’s Symbicort.

DRUGS

FDA has approved Progenics Pharmaceuticals’ Azedra (iobenguane) injection for IV use to treat adults and adolescents age 12 and older with pheochromocytoma or paraganglioma tumors that are unresectable, have spread beyond the original tumor site, and require systemic anticancer therapy. An agency statement says this is the first FDA-approved drug for this use.

FDA has approved an AbbVie NDA for Orilissa (elagolix), the first oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain. Approval is supported by data from two replicate Phase 3 studies involving nearly 1,700 women with moderate to severe endometriosis pain. Clinical trial data demonstrated Orilissa significantly reduced the three most common types of endometriosis pain — daily menstrual pelvic pain, non-menstrual pelvic pain and pain with sex, according to the company.

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