Vanda Pharmaceuticals, Inc. v. FDA, et al

  1. August 18, 2026

    DC Circ. Revives Part Of Fight Over Braille-Free Drug Label

    The D.C. Circuit on Tuesday partially vacated a lower court judgment that had upheld the U.S. Food and Drug Administration's approval of a label without braille for Teva Pharmaceuticals' generic version of a drug often prescribed to blind people.

  2. March 12, 2026

    DC Circ. Spends Hours Debating 'Same' Generic Label Reqs

    The D.C. Circuit spent more than three hours Thursday going round with Vanda Pharmaceuticals and the U.S. Food and Drug Administration about whether the label for a generic sleep-wake disorder medication is "the same" as the branded one because it doesn't include Braille.

  3. June 13, 2025

    DC Circ. Urged To Reject Approval For Braille-Free Drug Label

    Vanda Pharmaceuticals Inc. is urging the D.C. Circuit to reverse a lower court decision upholding the U.S. Food and Drug Administration's approval of a generic sleep-disorder drug without Braille labeling, a move the company argues jeopardizes patient safety.