Abbott secures FDA clearance for two over-the-counter glucose monitors

By Pratik Jain and Sriparna Roy

(Reuters) -Abbott Laboratories said on Monday the U.S. health regulator had cleared the company's two new over-the-counter glucose monitoring devices, expanding its presence in a fast-growing, multi-billion-dollar market.

The devices, one for the health-conscious and another for those with diabetes, follow the company's FreeStyle Libre, which generates over $1 billion every quarter and is sold under prescription for patients with diabetes.

One of the new OTC devices, Libre Rio, targets people with type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications.

The Food and Drug Administration's clearance for Libre Rio allows access to a continuous glucose monitor for 24.5 million type 2 diabetes patients who do not use insulin, RBC Capital Markets analyst Shagun Singh said.

The other product, Lingo, will help to track glucose and provide personalized insights to improve overall well-being.

Abbott plans to launch Lingo this summer, a spokesperson said, without disclosing details on pricing. The company said it would share details on pricing and availability of Libre Rio later.

Lingo is available in Britain since January for 120-150 pounds ($152-$190) per month.

Abbott believes the new devices combined can be at least a $1 billion plus in annual sales opportunity as a first stop, the RBC analyst said.

Libre Rio and Lingo will compete with Dexcom's Stelo, which in March became the first continuous glucose monitor to be approved by the FDA for OTC sales.

Shares of Abbott were up about 1% in morning trade.

(Reporting by Sriparna Roy and Pratik Jain in Bengaluru; Editing by Shailesh Kuber and Maju Samuel)