Qualitest Pharmaceuticals, Huntsville, AL, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

The drug company's Ballaspas Tablets were found by the agency to contain ergotamine tartrate, an ingredient used to treat vascular headaches and no longer covered by a current NDA.

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

Regarding labels, the agency stated 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 Bellamine S Tablets as currently formulated, manufactured, and labeled, is effective or safe, according to FDA. Lab; NDA; Doc. 14097W

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