Canadian Drug Distributor Dinged By FDA for ‘Misbranded’ Drugs (1)

Vulnerable patients with HIV, cancer, or other conditions importing their medicines to the U.S. via Canadian drug distributor CanaRx may have purchased unapproved drugs, the FDA said in a warning letter.

The Food and Drug Administration dinged CanaRx for ‘misbranded drugs’ and for substituting unapproved medicines for the FDA-approved prescription drugs patients expected to receive. The agency was particularly concerned the drug distributor sold foreign versions of medications for high-risk patient populations like Zortress—to prevent organ rejection in transplant patients—or Gleevec for cancer patients.

“Such vulnerable patient populations may have received drugs subject to a recall or may have experienced ...