Nucare Pharmaceuticals, Orange, CA, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

The letter stated that the company's Bellamine S Tablets, a drug product containing ergotamine tartrate used for treating vascular headaches, was determined by FDA to be a new drug and required an NDA.

The agency added that drug products containing ergotamine were marketed under NDAs approved for safety only before 1962.

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

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.

Also, though some ergotamine products were found to be effective for certain indications, this does not necessarily mean that Bellamine S Tablets as currently formulated, manufactured, and labeled, is effective or safe, according to FDA. Lab; NDA; Doc. 14096W

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