This section highlights FDA-related milestones and regulatory updates for drugs developed by Abbott Laboratories (ABT).
Over the past two years, Abbott Laboratories has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Deep, Esprit, Libre, Lingo, and Tendyne™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Deep brain stimulation (DBS) system - FDA Regulatory Timeline and Events
Deep brain stimulation (DBS) system is a drug developed by Abbott Laboratories for the following indication: Treatment-resistant depression (TRD), a form of major depressive disorder (MDD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Deep brain stimulation (DBS) system
- Announced Date:
- September 4, 2024
- Indication:
- Treatment-resistant depression (TRD), a form of major depressive disorder (MDD)
Announcement
Abbott announced that it has initiated a pivotal clinical trial, called the TRANSCEND study, to evaluate the use of the company's deep brain stimulation (DBS) system to manage treatment-resistant depression (TRD), a form of major depressive disorder.
AI Summary
Abbott has launched a major clinical trial called the TRANSCEND study to test its deep brain stimulation (DBS) system for treating treatment-resistant depression (TRD), a severe form of major depressive disorder. The trial aims to see if DBS, which works like a pacemaker sending electrical pulses to the brain, can help patients who have not found relief from other treatments. This innovative approach received Breakthrough Device designation from the FDA, which fast-tracks promising medical technologies that could significantly improve patient care.
The TRANSCEND study is a multi-center, double-blind, randomized, and sham-controlled trial that will involve 100 participants with TRD. The goal is to build solid clinical evidence about the safety and effectiveness of DBS for those suffering from this challenging condition, offering a potential new treatment option for people in need of alternative therapies.
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Esprit BTK System - FDA Regulatory Timeline and Events
Esprit BTK System is a drug developed by Abbott Laboratories for the following indication: for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK).
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Esprit BTK System
- Announced Date:
- April 29, 2024
- Indication:
- for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK).
Announcement
Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System), a breakthrough innovation for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK).
AI Summary
Abbott recently announced that the FDA has approved its groundbreaking Esprit™ BTK Everolimus Eluting Resorbable Scaffold System. This innovative device treats chronic limb-threatening ischemia (CLTI) below-the-knee by opening blocked arteries and releasing everolimus to support healing. Unlike traditional balloon angioplasty, which can lead to poor short- and long-term outcomes, the Esprit BTK System is a dissolvable stent that offers lasting support for approximately three years until the vessel can remain open naturally.
This FDA approval marks a major advancement for patients with severe peripheral artery disease, providing a new treatment option that could reduce the need for additional procedures. The Esprit BTK System promises improved outcomes and a significant shift in the management of CLTI, offering hope for those who previously had limited therapeutic alternatives.
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Libre Rio - FDA Regulatory Timeline and Events
Libre Rio is a drug developed by Abbott Laboratories for the following indication: for people with diabetes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Libre Rio
- Announced Date:
- June 10, 2024
- Indication:
- for people with diabetes
Announcement
Abbott announced U.S. Food and Drug Administration (FDA) clearance for two new over-the-counter continuous glucose monitoring (CGM) systems – Lingo™ and Libre Rio™, which are based on Abbott's world-leading FreeStyle Libre® continuous glucose monitoring technology1, now used by about 6 million people globally2.
AI Summary
Abbott has received FDA clearance for two new over-the-counter continuous glucose monitoring (CGM) systems – Lingo and Libre Rio – both based on the acclaimed FreeStyle Libre technology, now used by about 6 million people globally. These innovative devices bring advanced glucose tracking outside of the prescription market, expanding access to convenient health monitoring.
Lingo is crafted for adults looking to improve overall health and wellness by tracking glucose levels and receiving personalized coaching on lifestyle changes. In contrast, Libre Rio is specially designed for adults with Type 2 diabetes who do not use insulin and manage their condition with lifestyle modifications. By offering tailored features to suit different needs, Abbott aims to empower more individuals to take charge of their health using its world-leading biowearable technology.
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Lingo - FDA Regulatory Timeline and Events
Lingo is a drug developed by Abbott Laboratories for the following indication: to improve their overall health and wellness.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lingo
- Announced Date:
- June 10, 2024
- Indication:
- to improve their overall health and wellness.
Announcement
Abbott announced U.S. Food and Drug Administration (FDA) clearance for two new over-the-counter continuous glucose monitoring (CGM) systems – Lingo™ and Libre Rio™, which are based on Abbott's world-leading FreeStyle Libre® continuous glucose monitoring technology1, now used by about 6 million people globally2.
AI Summary
Abbott recently received U.S. FDA clearance for two new over-the-counter continuous glucose monitoring systems, Lingo™ and Libre Rio™, both based on its highly regarded FreeStyle Libre® technology. This technology is already trusted by about 6 million people around the world.
Lingo is aimed at general consumers who want to monitor their glucose levels to improve overall health and wellness, offering personalized insights and coaching to help build healthier habits. On the other hand, Libre Rio is designed for adults with Type 2 diabetes who do not use insulin and who usually manage their condition through lifestyle changes. It features a wide measurement range to effectively capture both low and high glucose events. This FDA approval marks a significant step in making glucose monitoring more accessible to different user groups, allowing more people to benefit from Abbott’s world-leading biowearable technology.
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Tendyne™ - FDA Regulatory Timeline and Events
Tendyne™ is a drug developed by Abbott Laboratories for the following indication: Transcatheter mitral valve replacement (TMVR) system.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Tendyne™
- Announced Date:
- May 27, 2025
- Indication:
- Transcatheter mitral valve replacement (TMVR) system
Announcement
Abbott announced the U.S. Food and Drug Administration (FDA) has approved the company's Tendyne™ transcatheter mitral valve replacement (TMVR) system to treat people with mitral valve disease.
AI Summary
Abbott announced that the U.S. Food and Drug Administration (FDA) approved its Tendyne™ transcatheter mitral valve replacement (TMVR) system for treating patients with mitral valve disease caused by severe calcium buildup in the valve’s supporting annulus. This condition, known as severe mitral annular calcification (MAC), can lead to life-disrupting symptoms like chest pain, shortness of breath, and dizziness, especially in patients who are too high risk for open-heart surgery.
The Tendyne system is designed as a minimally invasive alternative for patients whose valves are not suitable for repair or other treatment options. Delivered through a small chest incision, its self-expanding, fully repositionable, and retrievable design adapts to various patient anatomies, providing a critical new approach to reduce symptoms and improve quality of life for those suffering from complex mitral valve disease.
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