Superior Pharmaceuticals, Cincinnati, OH, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

FDA wrote that the company's Migracet-PB Suppositories contained ergotamine tartrate, which meant that the firm would have to apply for an NDA to continue to sell the product.

The agency also found 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.

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. 14100W

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