mechlorethamine HCl for injection [Mustargen]

Drug Shortage: Mustargen
Lundbeck Inc., the sole worldwide manufacturer of Mustargen (mechlorethamine HCl for injection), has informed the FDA that there will be an extended supply shortage of this drug.

A limited supply of Mustargen is expected to be available starting in mid/late April, and will be distributed by Lundbeck Inc. to meet current patient needs, with priority given to sites with patients currently receiving Mustargen. Once this limited supply is exhausted, a shortage is anticipated until early 2011. Pharmacies and physicians’ offices will need to call their distributor/wholesaler to obtain Mustargen on a drop ship basis only in order to meet patient needs when the drug product is released in mid/late April. Given the expected shortage, alternative treatment plans should be made for new patients to avoid interruption to a treatment program that would normally include Mustargen. The FDA has searched but is unaware of any other supplies of mechlorethamine HCl available from any other sources at this time.

Attached please find a letter from the manufacturer, Lundbeck Inc., concerning the shortage:
http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM207369.pdf1


Questions about the shortage can be directed to Drugshortages@fda.hhs.gov


Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm2, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm208079.htm