Coalition Asks FDA to Withdraw Approval of Pain Drug Zohydro ER

A coalition of more than 40 consumer organizations, health-care groups, addiction treatment providers and community-based drug and alcohol prevention programs sent a letter to the Food and Drug Administration asking the agency to revoke its approval of the pain drug Zohydro ER.

In October 2013, the FDA approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for managing pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate 11 PLIR 1317, 11/1/13. Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved, single-entity (not combined with an analgesic ...