Bio Pharm, Levittown, PA, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

FDA said the firm's products containing ergotamine tartrate, specifically, Migracet-PB Suppositories and Ergocaff PB Suppositories, were marketed under new drug applications approved for safety only prior to 1962.

FDA found that the company must apply for an NDA to continue to legally sell the products.

It also stated that the drugs are available for prescription only and must have labels with adequate directions for safe use.

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. Lab; NDA; Doc. 14083W

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