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The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) has issued an untitled letter to AstraZeneca for safety claims about the company’s cholesterol-lowering drug Crestor that the agency has deemed false and misleading.
Brand firm King Pharmaceuticals has announced it will restate its earnings results for 2002, 2003 and the first six months of 2004 — a move that could allow generic firm, Mylan Laboratories to pull out of a deal to purchase King without having to pay an $85 million penalty fee.
The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) has issued an untitled letter to Boehringer Ingelheim, citing the company for a sales aid promoting its antihypertensive drug, Micardis.
Pharmaceutical companies Pfizer and Mallinckrodt have been issued untitled letters from the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) for infractions related to promotional materials for their products.