Murfreesboro Pharmaceutical Nursing Supply, Murfreesboro, TN, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

The company's drug products containing ergotamine tartrate, specifically, Bellamine S Tablets and Eperbel S Tablets, were found by FDA to no longer be covered by a 1962 NDA and would need another for the products to be legally marketed.

Also, the agency found that 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. 14094W

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