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Dexamethasone, Fluconazole Approved by the FDA
LOS ANGELES, April 22 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, APP, , today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of dexamethasone sodium phosphate injection in 10mg/mL, 1mL vials. Dexamethasone, the generic equivalent of Merck & Co., Inc.'s Decadron® Phosphate Injection, is an adrenocortical steroid that is used in the treatment of acute disorders including, endocrine, hematologic, and rheumatic disorders; collagen, ophthalmic, gastrointestinal, respiratory, neoplastic and dermatologic diseases; and allergic states. APP expects to launch this product in late May 2003.
The company also announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application fluconazole injection in 2mg/mL, packaged in 200mg/100mL and 400mg/200mL single-dose vials. Fluconazole injection, the generic equivalent of Pfizer, Inc's Diflucan® Injection, is indicated for the treatment of vaginal candidiasis, oropharyngeal and esophageal candidiasis, and cryptococcal meningitis. APP may not market this product until the innovator patent expires on January 29, 2004.
"We believe our dexamethasone product will be the only preservative free, latex free and bar-coded product available on the market, which is an important consideration for hospitals, patients and healthcare providers," said Patrick Soon-Shiong, M.D., chairman, president and chief executive officer. "Sales of fluconazole were $179 million in 2002. We are pleased to add this relatively large market opportunity to our future product offering."
About American Pharmaceutical Partners, Inc.
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. The company is one of the largest producers of injectables, with more than 130 generic products in more than 350 dosages and formulations. APP has acquired the exclusive North American rights to manufacture and market a proprietary injectable oncology product, currently in Phase III clinical trials for metastatic breast cancer, which has been completely enrolled and for which the FDA has granted "Fast Track" product status. ABI-007 also is being studied in a variety of other cancers. For more information, visit APP's website at http://www.appdrugs.com/ .
Statements contained in this press release, which are not historical facts, are forward-looking statements, as the term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements, whether expressed or implied, are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated, due to a number of factors, which include, but are not limited to, the impact of pharmaceutical industry regulation, the difficulty in predicting the timing or outcome of product development efforts and FDA or other regulatory approvals or actions, 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, actual results achieved in Phase III and further Phase II trials for ABI-007 which may or may not be consistent with results achieved in Phase I and Phase II trials, the timing and completion of the ABI-007 trials, and other risk factors discussed in the Company's Form 10-K and other documents filed by the Company with the Securities and Exchange Commission from time to time. These forward-looking statements represent 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.
Decadron is a registered trademark of Merck & Co., Inc.
Diflucan is a registered trademark of Pfizer, Inc