Teva Takes Swipe At Mylan In Seventh Petition To Block Copaxone Generics
This article was originally published in The Pink Sheet Daily
New data on foreign generics may not be enough to sway FDA.
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Revlimid, Copaxone, Sensipar, Enbrel, Acthar Gel and Gleevec will be the subject of a US House Committee on Oversight and Reform in an upcoming drug price hearing.
Promotion does not adequately communicate the diabetes drug’s indication, limits of use and risks, FDA says. It objects to distracting visuals in video and less prominent risk information. Agency had previously relayed its concerns to Lilly about Trulicity promotions.
Generic manufacturers are being cautious on label carve-outs to avoid claims of induced infringement. Bright line rules are necessary, attorney says, and if GSK v. Teva decision is not reversed, legislation will be needed to preserve skinny label. Insurers also face potential liability for placement of skinny-label generics on formularies.