LXN plans U.S. launch of Duet fructosamine/glucose monitor in early 1998.
This article was originally published in The Gray Sheet
LXN CORP. U.S. SHIPMENTS OF DUET O-T-C FRUCTOSAMINE/GLUCOSE MONITOR will begin in early 1998 at the earliest, the firm says. LXN received 510(k) clearance June 13 for over-the-counter sale of the monitor for use by diabetics to measure fructosamine. The firm, which obtained FDA clearance in June 1996 for self-measurement of glucose with the same meter, will defer marketing until it is able to offer both tests together. Discussions with FDA are ongoing to determine if an additional 510(k), or supplemental data to the fructosamine 510(k), would be required to market the Duet for measuring glucose and fructosamine at the same time.
You may also be interested in...
Second read-out maintains 94% level of efficacy, with a very early signal that it could outperform Pfizer’s rival mRNA candidate in preventing severe cases.
The French major and Regeneron have racked up another indication for Dupixent with the blockbuster getting approval in Europe to treat children with severe eczema.
Russia says it will make the first deliveries of its $10-per-dose Sputnik V vaccine in January, while international regulators say vaccine trials should continue for as long as possible to generate longer-term evidence on their benefits and risks. A UK research body has stressed that drugs repurposed for COVID-19 also need to undergo thorough safety and efficacy testing as reports suggest the UK regulator could approve a vaccine within days.