Ferndale Laboratories, Ferndale, Ml, Feb. 26, 2007 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

The company, a manufacturer of drug products containing ergotamine tartrate, specifically, phenobarbital, ergotamine, and belladonna tablets, Bellamine Tablets, and Spas trin Tablets, was informed by FDA that these are new drugs and must have an NDA to be sold.

It stated that drug products containing ergotamine were marketed under NDAs approved for safety only before 1962, the agency stated. It noted that the firm must apply for an NDA to continue to legally sell the products.

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

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, FDA added. Lab; NDA; Doc. 14089W

Print Get the Mag Weekly Updates