Breckenridge Pharmaceutical, Boca Roton, FL, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

The company's Spastrin Tablets and Bellcomp-PB Suppositories drug products used in the treatment of vascular headaches were determined to contain ergotamine tartrate, which the agency stated needed an NDA to be marketed legally in the future.

The drug is available only by prescription and must have a label that has adequate directions for use, the agency noted.

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. NDA; LAB; Doc. 14084W

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