APP Coordinating with FDA to Alleviate Critical Shortage of Propofol Injection in the United States
Following two recent voluntary recalls from other manufacturers of propofol injection, there is now a critical shortage of this important medication in the United States market. APP Pharmaceuticals, at the request of the FDA, is coordinating with the agency to alleviate these shortages of propofol injection by increasing supply of other propofol products. APP has historically collaborated with the FDA to offset a critical shortage of important medications following product recalls from other suppliers.
The FDA has chosen to address this shortage in the US market by making available an international propofol 1% product labeled as Fresenius Propoven 1% (propofol 1%). Fresenius Propoven 1% (propofol 1%) is manufactured by APP’s parent company Fresenius Kabi AG, whose manufacturing facilities are in compliance with the FDA. Fresenius Kabi AG is the world market leader of this anesthetic and the Fresenius formulation of Propofol is used in more than 84 countries worldwide. APP anticipates Fresenius Propoven 1% (propofol 1%) will be used to address the shortage until the marketplace stabilizes. Customers can begin placing orders immediately and APP is expected to begin distribution of this product no later than Wednesday, November 18, 2009.
Propofol is a general anesthetic used to start or maintain anesthesia during certain surgeries, tests, or procedures and is distributed by APP under the brand name DIPRIVAN® (propofol 1%). In addition to distributing Propoven, APP will continue to increase supplies of DIPRIVAN® to alleviate the shortage of this important medication.
To view the Dear Healthcare Professional Letter, click here. To view a clinical comparison of APP's DIPRIVAN® and Fresenius Propoven click here. For a list of Frequently Asked Questions, click here.
Contact APP's Medical Information department at 1-800-551-7176 between the hours of 8 a.m. and 5 p.m. (CST), or e-mail appmedicalinfo@APPpharma.com if you have any questions about the safe and effective use of Fresenius Propoven 1% (propofol 1%).
If you have additional questions regarding product availability, please contact APP's Customer Service at 1-888-386-1300, Monday – Friday, between the hours of 7:00 a.m. and 6:00 p.m. (CST).
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On October 1, 2009, the implementation of the new USP monograph for unfractionated heparin will go into effect. The purpose of the USP monograph changes are to further assure the purity of the Active Pharmaceutical Ingredient (API) through specific assay tests and calibrate activity to align with the International Standard (IS) issued by the World Health Organization (WHO). As a proven leader in providing safe, efficacious and rigorously tested heparin products to the U.S. market, APP has always met or exceeded USP standards and will implement and meet the new USP standards. In order for customers to clearly differentiate product tested using the new USP standards, APP will be incorporating an "N" (for "new") after the expiration date on every vial. An example of the new vial label pictured here can be also be seen by clicking on this link. For more information on APP products, please contact Customer Service at (888) 386-1300 between the hours of 7:00 a.m. and 6:00 p.m. CT. For clinical and technical questions regarding APP products, please call the Medical Information and Safety Department at (800) 551-7176 between the hours of 8:00 a.m. and 5:00 p.m. CT or contact us via e-mail at APPMedicalInfoUSP@APPpharma.com. |
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