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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-10/
- Published: 2020-06-21T12:00:00.000Z
- Updated: 2026-09-14T16:18:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141997

**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](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614550.htm?ref=fdaweb.com) 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](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615155.htm?ref=fdaweb.com) 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.