Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.GlaxoSmithKline or GSK and XenoPort, a biopharmaceutical company, have announced that GSK has resubmitted the new drug application to the FDA requesting approval of Solzira extended release tablets for the treatment of moderate-to-severe primary restless legs syndrome.
Subscribe to our email newsletter
The FDA had requested that the data in a single study be reformatted. In addition, GSK conducted a review of other clinical studies taking this input into account. The withdrawal was not related to the content of the filing.
Solzira is a new entity that is designed to improve upon the pharmacokinetics of gabapentin by taking advantage of high-capacity transport mechanisms in the gastrointestinal tract to improve absorption.