FDA Warns Canadian Pharmacy for Trying to Sell Unapproved Drug to Onfi Patients

The FDA is warning a pharmacy in Vancouver for continuing to sell its unapproved clobazam to U.S. patients despite the agency’s approval of Lundbeck’s Onfi in 2011. Mark’s Marine Pharmacy also was warned over letters it sent to U.S. patients and physicians, informing them that they can continue to receive clobazam even if it will not be used to treat Lennox-Gastaut syndrome, which is the only FDA-approved indication for Onfi (clobazam).
Drug Industry Daily