McGuff Company News Room

FDA asks EDTA Manufacturers to Stop

May 27, 2008

The Food and Drug Administration (FDA) withdrew approval of one new drug application (NDA) and two abbreviated new drug applications (ANDAs) for edetate disodium injection (EDTA). The holders of these applications have agreed in writing to permit FDA to withdraw approval of the applications and have waived their opportunity for a hearing.

As of 05/27/08 McGuff Medical will no longer be able to supply Edetate Disodium for Injection, 150mg/mL, 20mL SD vial (EDTA) to customers. EDTA is now available from McGuff Compounding Pharmacy Services, Inc.

• McGuff Compounding Pharmacy Services, Inc.
• 2921 West MacArthur Blvd.
• Suite 142
• Santa Ana, CA 92704-6929
• tel 1-877-444-1133
• fax 1-877-444-1155
• Email: pharmacyanswers@mcguff.com
• Website: www.mcguffpharmacy.com

Purchasing EDTA from McGuff Compounding Pharmacy Services, Inc. may require different procedures as the pharmacy operates under separate laws and regulations than McGuff Company, Inc. Additionally, the McGuff Compounding Pharmacy is able to provide EDTA at a lower cost than the commercial EDTA provided by Bioniche, a manufacturer located in Ireland.

This change affects only one drug, commercially manufactured EDTA. The McGuff Company continues to provide over 5,000 other drugs, devices and miscellaneous products.

Please remember! EDTA is Edetate Disodium for Injection and CaEDTA is Calcium Edetate Disodium for Injection - These are two different drugs. Both are available from McGuff Compounding Pharmacy Services, Inc.

For further information:

• Federal Register: June 12, 2008 (Volume 73, Number 114)][Notices]
• [Page 33440-33441] From the Federal Register Online via GPO Access
• http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-13273.htm

• FDA Public Health Advisory
• http://www.fda.gov/cder/drug/advisory/edetate_disodium.htm

• Questions and Answers on Edetate Disodium (marketed as Endrate and generic products)
• http://www.fda.gov/Cder/drug/infopage/edetate_disodium/QA.htm