SDA Laboratories, Greenwich, Connecticut, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

This firm was sent a letter stating that its manufacture of Ergocaff PB suppositories was no longer covered by a current NDA, and that the company would need to apply for another one.

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 Ergocaff PB Suppositories 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.

On labeling, the firm must provide a warning regarding possible risks of life-threatening ischemia, including fatalities and cases of gangrene, which have resulted from con comitant use. Lab; NDA; Doc. 14099W

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