IMPAX Receives FDA Approval to Market Sotalol Hydrochloride Tablets; -IMPAX's Fourth ANDA Approval-.

Business/Health & Medical Editors

HAYWARD, Calif.--(BW HealthWire)--Nov. 9, 2000

IMPAX Laboratories, Inc. (NASDAQ NM:IPXL) today announced that the United States Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) to market Sotalol Hydrochloride Tablets, a generic version of Betapace(R).

Betapace, which is marketed by Berlex Laboratories for the treatment of documented ventricular arrhythmias, had sales of approximately $140 million in the U.S. during 1999. IMPAX's Global Pharmaceuticals division will begin marketing the product immediately. The FDA has approved several other generic versions of Betapace in recent months.

"We believe that the approval of this ANDA along with several submissions pending at FDA demonstrate the ongoing progress in our research and development area," said Larry Hsu, Ph.D., President and Chief Operating Officer of IMPAX Laboratories. "This is our second ANDA approval this year, and our fourth overall. We intend to continue our strategy of developing and marketing controlled release and niche generics, as well as branded pharmaceuticals."

IMPAX currently has a total of seven ANDAs pending at the FDA addressing over $5.1 billion in U.S. branded product sales. Of these, four are controlled release generic ANDAs that address almost $4.8 billion in product sales, and three are niche generic ANDAs that address approximately $350 million in branded product sales. During the next 18 months, the Company plans to submit to the FDA up to nine additional controlled release product ANDAs addressing approximately $4.2 billion in brand sales, and up to 11 additional niche product ANDAs addressing over $350 million in brand sales. Additionally, three development projects have been initiated for IMPAX's own line of branded products focused on central nervous system (CNS) disorders. The therapeutic categories being targeted currently total $4 billion in sales. The Company expects to submit the first of these to the FDA during 2001.

"We are pleased with the rate at which our product pipeline is developing," said Barry R. Edwards, Co-Chief Executive Officer of IMPAX Laboratories. "Overall, our current pipeline includes more than 30 projects addressing almost $10 billion in U.S. branded product sales."

IMPAX Laboratories, Inc. combines the advanced drug delivery systems developed by Impax Pharmaceuticals with the packaging, marketing and sales capabilities of Global Pharmaceuticals. The Company continues to expand its development of controlled-release and niche generics while accelerating the development of branded products. IMPAX Laboratories is headquartered in Hayward, Calif., and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at www.impaxlabs.com.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:

To the extent any statements made in this 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, 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.