Excellium Pharmaceutical, Fairfield, NJ, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

The firm's Eperbel S Tablets, a drug product containing ergotamine tartrate for the treatment of vascular headaches, was determined to need an NDA to continue to be marketed for sale. Drug products containing ergotamine were marketed under NDAs approved for safety only before 1962, the agency stated.

Additionally, the warning letter stated that the drugs are available for prescription only and must have labels with adequate directions for safe use.

Next, 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. Lab; NDA; Doc. 14088W

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