SCHAUMBURG, Ill., April 29 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of Adenosine Injection, USP, 3 mg/mL, packaged in 6 mg/2mL and 12mg/4mL single use vials, the generic equivalent of Fujisawa's Adenocard(R) Injection. The company expects to commence marketing this product shortly.
Adenosine injection is indicated for the following: conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts, (Wolff-Parkinson-White Syndrome).
"Adenosine injection is provided primarily in syringes, however we believe the market is converting to vials," said Al Heller, president and chief executive officer. "Adenosine represents APP's third ANDA approval in 2005 and adds further breadth to our critical care line."
According to IMS, sales of adenosine injection (vials and syringes) were approximately $31 million in 2004.
About American Pharmaceutical Partners
American Pharmaceutical Partners, Inc. is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets. Abraxis Oncology, the proprietary division of APP, is devoted entirely to developing and promoting innovative, next-generation cancer therapies such as ABRAXANE(TM), recently launched for the treatment of metastatic breast cancer. For more information, visit APP's website at http://www.appdrugs.com/ and http://www.abraxisoncology.com/.
This press release contains forward-looking statements within the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. All statements included or incorporated by reference in this press release, other than statements that are purely historical, are forward-looking statements. The words "may," "will," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "continue," and similar expressions identify forward-looking statements. Forward-looking statements also include the assumptions underlying or relating to any forward-looking statements.
Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the ability to successfully market Adenosine Injection, the difficulty in predicting the timing or outcome of other product research and development efforts, potential product characteristics and indications, marketing approvals and launches of other products, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in the Company's Form 10-K for the year ended December 31, 2004 and other documents filed by the Company with the Securities and Exchange Commission.
The forward-looking statements in this press release reflect the Company's judgment as of the date of this press release. The Company disclaims any intent or obligation to update these forward-looking statements.
Adenocard(R) Injection is a registered trademark of Fujisawa Pharmaceutical Co.
American Pharmaceutical Partners, Inc.