DDMAC UNTITLED LETTERS.The following untitled letters were issued by the Center for Drugs Division of Drug Marketing, Advertising and Communications (DDMAC DDMAC Division of Drug Marketing, Advertising and Communications ). Copies of these letters are available to subscribers from our RECORD-RETRIEVE Service for $7 plus retrieval. Please reference the MACMIS ID # to order the company response. 9209W Allergan, Irvine, CA, July 24 (DDMAC). The letter stated that the firm's journal ad and "Dear Doctor" letter promoting Azelex (azelaic acid) was for a drug that had not received clearance from 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. . The agency also noted that superiority claims made in comparison to Benzamycin, made by Dermik Labs, were false or misleading because Azelex was not yet approved. ID # 8735 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 9210W AstraZeneca, Chesterbrook, PA, May 26 (DDMAC). FDA stated that the firm's 16-page visual aid for Accolate (zafirkulast) failed to disclose information regarding the drug's effect on eosinophils Eosinophils A leukocyte with coarse, round granules present. Mentioned in: Histiocytosis X eosinophils . F-B |
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