Harvard Drug Group (formerly Major Pharmaceuticals), Livonia, MI, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

The letter advised that the company's drug products contained an ingredient--ergotamine tartrate--used to treat vascular headaches, but the product was approved for safety only prior to 1962.

The agency stated that the company would have to apply for an NDA for the drug to be sold.

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.

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

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. Lab; NDA; Doc. 14090W

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