Lini, Rahway, NJ, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

FDA stated that the company's Bell Phen Ergot S Tablets, Bellaspas Tablets, and Bellamine Tablets drug products contained ergotamine tartate and would require an NDA to be marketed for sale.

These type of drug products containing ergotamine were marketed under NDAs approved for safety only before 1962.

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

Next, the letter advised that the label must have 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. NDA, Lab; Doc. 14093W

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