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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-80/
- Published: 2019-01-27T12:00:00.000Z
- Updated: 2026-09-15T00:57:39.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140903

**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; in9/2017, Verzenio became the first cyclin-dependent kinase 4 & 6 inhibitor approved in combination and as a single agent in metastatic breast cancer.