DSC Laboratories, Muskegon, Ml, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

The agency warned the firm regarding its drug products containing ergotamine tartrate, specifically, caffeine ergotamine, and pentobarbital suppositories and Bellcomp PB suppositories, for the treatment of vascular headaches.

Drug products with 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.

It further noted that the drugs are available for prescription only and must have labels with adequate directions for safe use.

Also, 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.

FDA stated that the firm must respond with the following information:

* A statement of what action the firm plans to take to comply;

* A statement of the amount of each drug, caffeine ergotamine, and pentobarbital suppositories and Bellcomp PB suppositories, and any other unapproved ergotamine containing product, that is in inventory under its control;

* The time period in which the company expects such inventory to be exhausted, in their entirety, and the plan for disposition of any inventory remaining after the above shipment cessation date; and

* An estimate of when products in distribution channels will become exhausted. Lab; NDA; Doc. 14087W

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