DDMAC UNTITLED LETTERS.

The following untitled letter was issued by the Centers for Drugs' Division of Drug Marketing, Advertising and Communications (DDMAC). Copies of this and other letters are available to subscribers from our RECORD-RETRIEVE service for $7 plus retrieval. Please reference the MACMIS ID # to order the company response.

9912W

Abbott Labs, Abbott Park, IL, Jan. 18 (DDMAC). The letter cited Abbott's sales aid for Mivacron (mivacurium chloride) for misleading efficacy claims because the drug was described as "the only short-acting, non-depolarizing neuromuscular blocker with an established a safety profile." FDA insisted that Raplon (rapacuronium bromide) exhibited the same characteristics. The agency cited the sales aid for lack of fair balance because it failed "to present any risk information other than the disclosure of the single most common adverse event." ID # 9426. F-B