DRX Pharmaceutical Consultants, Skokie, IL, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

The company was informed that its Bellamine S Tablets, a drug product containing ergotamine tartrate, to treat vascular headaches, must have a current NDA to be sold legally because the drugs were approved for safety only before 1962.

Also, FDA stated that 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.

Further, the company was warned that the label must have adequate instructions for use. Lab; NDA; Doc. 14086W

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