APP Increasing Production of APP Propofol 1% (authorized generic DIPRIVAN®)
and DIPRIVAN® (propofol 1%)

APP Pharmaceuticals recognizes how vital it is for clinicians and patients to receive a consistent supply of propofol. As a result of the critical ongoing shortage of Propofol Injection in the United States, APP has increased its production of APP Propofol 1% (authorized generic DIPRIVAN®) and DIPRIVAN® (propofol 1%).

Because of a commitment to our customers, APP acted decisively to increase supply at the onset of this critical market shortage. During this time, we have:

• Increased production of APP Diprivan®
• Initiated and have increased production of APP authorized generic Propofol
• Supplemented supply by importing international Fresenius Propoven 1% (propofol 1%), in agreement with the FDA.

APP is owned by Fresenius Kabi, the largest manufacturer of propofol injection in the world. The combined efforts of APP and Fresenius Kabi have focused on increasing propofol supply by bringing new capacity on line and as a result APP is currently producing at levels to supply the entire U.S. market.

At a significant incremental cost, APP is using air-freight to accelerate overseas deliveries from multiple European manufacturing facilities into the United States to ensure hospitals and clinics receive continual access to product. APP will continue these efforts until propofol supplies stabilize.

APP previously received FDA approval to import and distribute Fresenius Propoven 1% (propofol 1%) to help alleviate shortages following two voluntary recalls from other manufacturers of propofol injection. On March 9, 2010, APP reintroduced Fresenius Propoven 1% (propofol 1%) to alleviate the ongoing shortage following continued supply issues from other manufacturers; however quantities are limited. APP is committed to providing the US market with available quantities of Fresenius Propoven 1% (propofol 1%), DIPRIVAN® (propofol 1%) and APP Propofol 1% (authorized generic DIPRIVAN®) and anticipates Fresenius Propoven (propofol 1%) will be used to address the shortage until the marketplace stabilizes.

Fresenius Propoven 1% (propofol 1%) is manufactured by APP’s parent company Fresenius Kabi AG, in FDA compliant facilities. The Fresenius Propoven 1% formulation of Propofol is used in more than 39 countries worldwide. APP will continue to ship Fresenius Propoven (propofol 1%) until APP and Fresenius Kabi's increased manufacturing capacity can sufficiently supply the market.

To prevent unauthorized resale, no other entity, except APP, is authorized by the FDA to import or distribute Fresenius Propoven 1% (propofol 1%). Any sales of Propoven 1% from any entity other than APP will be considered a violation of the Food, Drug and Cosmetic Act and will be subject to enforcement.

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%) and Propofol 1% (authorized generic DIPRIVAN®).

To view the Dear Healthcare Professional Letter, click here. To view a clinical comparison of APP’s DIPRIVAN® and Fresenius Propoven 1% 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 (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).