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Generic Equivalent of Brethine Gains FDA Approval

SCHAUMBURG, Ill., May 28 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. (Nasdaq: APPX - News) today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Terbutaline Sulfate Injection, USP. Terbutaline is indicated for the prevention and reversal of bronchospasm in patients over the age of 12 with bronchial asthma and reversible bronchospasm associated with bronchitis and emphysema, and is the generic equivalent of aaiPharma Inc.'s Brethine® Injection. APP expects to commence marketing terbutaline shortly.

"We received this ANDA approval only seven months after it was submitted, which underscores the ability of our regulatory team and quality of our applications," said Patrick Soon-Shiong, M.D., chairman, president and chief executive officer of American Pharmaceutical Partners. "Terbutaline is an important addition to our critical care product offering and brings to four the number of ANDA approvals APP has received thus far in 2004." Soon-Shiong noted that sales of terbutaline were approximately $44 million in 2003.

APP is committed to providing a safer hospital environment and, to that end, will offer its terbutaline product in vials as opposed to glass ampules that are fragile and prone to breaking. The innovator currently offers its product in glass ampules.

Source: American Pharmaceutical Partners, Inc.

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