United Research Laboratories and Mutual Pharmaceutical Company, Philadelphia, PA, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY

The company's Bel-Tab tablets were found to contain ergotamine tartrate, which is used to treat vascular headaches, including migraines and migraine variants.

The firm was advised that it would have to apply for a current NDA if it wished to continue to sell the product.

The agency stated about labeling that the product 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 Bel-Tab tablets as currently formulated, manufactured, and labeled, is effective or safe, according to FDA. Lab; NDA; Doc. 14101W

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