LOS ANGELES, Feb. 6, 2002 (PRIMEZONE) -- American Pharmaceutical Partners (Nasdaq:APPX) announced today that it has received U.S. Food and Drug Administration approval for its Abbreviated New Drug Application (ANDA) ketorolac tromethamine injection, USP, in 15 mg, 30 mg and 60 mg strength single-dose vials. This brings to 14 the number of ANDA approvals American Pharmaceutical Partners (APP) has received in the last 12 months.
Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) frequently prescribed to relieve moderately severe pain, and is the generic equivalent of Hoffmann-La Roche Inc.'s Toradol(r). The company's version of ketorolac is 100 percent latex-free and bundled in packages of 25; marketing will commence in February.
APP also announced that it will be the first to include bar codes on every vial of generic ketorolac in an effort to reduce dosing and administration errors.
"Placing bar codes on vials of generic ketorolac is important to help ensure patients receive the right drug and at the appropriate strength," said Patrick Soon-Shiong, M.D., chairman, president and chief executive officer. "We are committed to helping hospitals safely administer pharmaceuticals by expanding the practice of including bar codes on our other injectable products."
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. APP has acquired the exclusive North American rights to manufacture and market a proprietary injectable oncology product, currently in advanced clinical trials and being studied in a variety of cancers. The company is also one of the largest producers of injectables, with more than 100 generic products in more than 300 dosages and formulations. For more information, visit APP's website at 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, and other risk factors discussed in the Company's prospectus dated December 13, 2001 and documents filed by the Company with the Securities and Exchange Commission from time to time.