Centrix Pharmaceutical, Birmingham, AL, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

The letter stated that the company's Ergocaff PB Suppositories, a drug product containing ergotamine tartrate for treatment of vascular headaches, were approved for safety only before 1962 and that the drug must have a current NDA to be legally marketed.

FDA also stated that the drug is available only by prescription and must have a label that has adequate directions for use. Also, the label must bear a warning regarding possible risks of life-threatening ischemia, including fatalities and cases of gangrene, which have resulted from concomitant use.

Additionally, the agency noted that even though some ergotamine products were found to be effective for certain indications, this does not necessarily mean that Ergocaff PB Suppositories as currently formulated, manufactured, and labeled, is effective or safe. NDA; LAB; Doc. 14085W

Print Get the Mag Weekly Updates