Sandoz, Princeton, NJ, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

The letter stated that the firm was a manufacturer of phenobarbital, ergotamine, and belladonna tablets, which contain ergotamine tartrate. This ingredient is not covered by a current NDA.

The agency stated that unapproved drugs are a public health risk because they may not meet modern standards for safety, effectiveness, quality, and labeling.

Even though some ergotamine products were found to be effective for certain indications, this does not necessarily mean that the firm's products as currently formulated, manufactured, and labeled, is effective or safe, according to the letter.

Further, FDA warned 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. Lab; NDA; Doc. 14098W

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