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Brethine, which is marketed by Novartis for the prevention and reversal of bronchospasm, had sales of approximately $15 million in the U.S. during 2000. IMPAX's Global Pharmaceuticals
division will begin marketing the product immediately.
"This is our fifth ANDA approval and the first one this year," said Larry Hsu Ph.D., IMPAX's president and COO
. "We are pleased to add Terbutaline Sulfate Tablets to our growing portfolio of
products. As the first generic version of Brethine, this product will offer both patients and payors a cost-effective alternative to the brand."
IMPAX currently has nine ANDA filings pending at the FDA that address more than $5.7 billion in annual U.S. branded product sales. Seven of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.
IMPAX Laboratories Inc. is a technology-based specialty pharmaceutical company applying its formulation expertise and drug-delivery technology to the development of controlled-release and niche generics, in addition to the development of branded products.
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IMPAX markets its generic products through its Global Pharmaceuticals division and intends to market its branded products through the IMPAX Pharmaceuticals division. IMPAX Laboratories has headquarters in Hayward, Calif., and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, visit the company's Web site at www.impaxlabs.com.
"Safe Harbor
" Statement Under the Private Securities
Litigation
Reform Act
To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against the company, availability of raw materials, the regulatory environment, fluctuations in operating results, and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission.
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