IMPAX Receives Final FDA Approval for Generic Version of Claritin-D 24-Hour; Third ANDA Approval of 2004 for IMPAX

March 05, 2004

HAYWARD, Calif.--(BUSINESS WIRE)--March 5, 2004--IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Claritin(R)-D 24-Hour (Loratadine and Pseudoephedrine Sulfate, 10mg/240mg) Extended Release Tablets. Schering-Plough Corporation (NYSE:SGP) markets Claritin-D 24-Hour as an over-the-counter (OTC) drug for the relief of symptoms of seasonal allergic rhinitis (hay fever). According to NDCHealth, U.S. sales of Claritin-D 24-Hour were $39 million for the 12 months ended December 31, 2003. The Company is working with its marketing partner toward the commercial launch of this product.

"This is our third ANDA approval in 2004, and reflects the strength of both our R&D and regulatory teams," said Larry Hsu, Ph.D., IMPAX's President. "We are pleased to add Loratadine and Pseudoephedrine Sulfate, 10mg/240mg Extended Release Tablets to our growing portfolio of marketed products."

IMPAX currently has 19 applications pending at the FDA, including five tentatively approved, which address approximately $6.8 billion in U.S. branded product sales for the 12 months ended December 31, 2003. Fourteen 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 specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and intends to market its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at:

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

To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Impax's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, Impax's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, Impax's ability to successfully develop and commercialize pharmaceutical products, Impax's reliance on key strategic alliances, the uncertainty of patent litigation, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in Impax's filings with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and Impax undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.

    CONTACT: IMPAX Laboratories, Inc.
             Barry R. Edwards (CEO), 215-289-2220 Ext. 1771
             Larry Hsu, Ph.D. (President), 510-476-2000 Ext. 1111
             Cornel C. Spiegler (CFO), 215-289-2220 Ext. 1706
             Investor Relations:
             Lippert/Heilshorn & Associates, Inc.
             Kim Sutton Golodetz, 212-838-3777 (
             Bruce Voss, 310-691-7100 (

    SOURCE: IMPAX Laboratories, Inc.