Ivax Pharmaceuticals, Miami, FL, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

FDA warned the company regarding its marketing of Bel-Phen-Ergot S Tablets, a drug product containing ergotamine tartrate. This product is used to treat vascular head aches and previously was marketed under an NDA approved for safety only prior to 1962.

According to the letter, the drug product now requires an NDA to continue be sold legally.

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

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.

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. 14091W

Print Get the Mag Weekly Updates