Released by FDA: 1/18/01.  Posted by FDA:  1/19/01

Thomas F. Wilier, Ph.D. 
Associate Director, Regulatory Affairs 
Hospital Products Division 
Abbott Laboratories 
D-389, Bldg. AP30
200 Abbott Park Road 
Abbott Park, Illinois 60064-6157

RE:   NDA 20-098 
        Mivacron (mivacurium chloride) Injection 
        MACMIS ID # 9426

Dear Dr. WilIer:

We refer to Abbott Laboratories’ (Abbott) submission, dated November 11, 2000, of promotional material under cover of Form FDA 2253 for Mivacron (mivacurium chloride) Injection.  This submission included a professional sales aid, identified as 00-7337.  The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed this professional sales aid and has concluded that it is in violation of the Federal Food. Drug. and Cosmetic Act and its implementing regulations. Our specific objections follow:

Misleading Efficacy Claims

• You present the claim. “Mivaeron is the only short-acting, nondepolarizing NMB [neuromuscular blocker] with an established safety profile.”  This claim is misleading because it suggests that Mivacron is the only safe short-acting, nondepolarizing NMB.  However, Raplon (rapacuronium bromide) for Injection is also a nondepolarizing NMB that has a short duration of clinical action.

• The claim, "[Mivacron] Ensures confidence of administration even in patients with significant cardiovascular disease,” is misleading because it minimizes the risk of using Mivacron in patients with significant cardiovascular disease.  Specifically, the Precautions section of the P1 states, “Caution should be exercised in administering Mivacron to patients with clinically significant cardiovascular disease and patients with any history suggesting a greater sensitivity to the release of histamine or related mediators (e.g. asthma).”   Furthermore. cardiovascular disease is a condition that warrants a Mivacron dosage adjustment.  Specifically, the P1 states, “the initial dose of Mivacron should he 0.1 5 mg/kg or less, administered over 60 seconds and assurance of adequate hydration and careful monitoring of hemodynamic status are important.

Fair Balance

• In general, claims for a drug should he accompanied by infommtion about the most serious and the most common adverse events associated with the use of the drug.  Although you present numerous claims for Mivacron in your sales aid, you fail to present any risk information other than the disclosure of the single most common adverse event.  Therefore. this sales aid lacks fair balance because important risk information is omitted.

In order to address these violations, you should immediately cease distribution of this and other similar promotional materials for Mivacron that contain the same or similar messages.  You should submit a written response to us on or before February 1, 2001. describing your intent to comply with the above.

You should direct your response to me by facsimile at (301) 594-6771, or in writing at the Food and Drug Administration. Division of Drug Marketing, Advertising and Communications, HFD- 42, Rm.17B-20, 5600 Fishers Lane, Rockville, MD 20857. We remind you that only written communications are considered official.

Sincerely,

Spencer Salis, Pharm.D. 
Regulatory Review Officer 
Division of Drug Marketing, 
    Advertising and Communications