Bio Pharm, Levittown, PA, Feb. 26 (Rockville, MD).FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. said the firm's products containing ergotamine tartrate, specifically, Migracet-PB Suppositories suppositories, n.pl solid capsules made of materials that melt at body temperature and are used to deliver medicinal substances into the rectum. and Ergocaff PB Suppositories, were marketed under new drug applications approved for safety only prior to 1962. FDA found that the company must apply for an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any to continue to legally sell the products. It also stated 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 gangrene, local death of body tissue. Dry gangrene, the most common form, follows a disturbance of the blood supply to the tissues, e.g., in diabetes, arteriosclerosis, thrombosis, or destruction of tissue by injury. , which have resulted from concomitant use. Lab; NDA; Doc. 14083W |
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