Merck’s new injectable basal insulin, LUSDUNA Nexvue, has been tentatively approved by the FDA. This biologic insulin has yet to receive full approval, however, due to a patent infringement lawsuit. Merck was sued in September 2016 by Sanofi, which has accused the other company of infringement regarding Lantus injectable insulin.
According to the Hatch-Waxman Act, the FDA cannot provide LUSDUNA Nexvue with full approval until either the lawsuit is settled in Merck’s favor or it has been 30 months since the lawsuit was filed, whichever comes first.
These findings were published in Medpage Today, on July 20, 2017.