CHAPEL HILL, N.C. – Pozen has formally filed revised information with the Food and Drug Administration in another attempt to win FDA approval of its proposed migraine drug.
Pozen is developing the pain reliever Trexima along with GlaxoSmithKline.
The FDA rejected Pozen’s submission in June 8. A revised submission was rejected in December. The FDA has up to six months to review the revised information, according to Pozen.
Trexima is a combination of the GSK pain reliever Imitrex and a pain reliever known as naproxen. The two are combined utilizing Pozen technology.