Company's Eighth Paragraph IV ANDA Filing
February 12, 2002 -- IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced
that the U.S. Food and Drug Administration (FDA) has accepted the Company's
filing of an Abbreviated New Drug Application (ANDA) for a generic version of
Allegra-D® (Fexofenadine HCl/Pseudoephedrine HCl) Extended Release 60 mg/120mg
Tablets.
Aventis Pharmaceuticals Inc. markets Allegra-D® for the relief of symptoms
associated with seasonal rhinitis in adults and children 12 years of age and
older. U.S. sales of Allegra-D® Extended Release Tablets were over $350
million in 2001.
IMPAX's application includes a certification under Paragraph IV of the Hatch-Waxman
Amendments stating the Company's belief that its product does not infringe Aventis
Pharmaceuticals Inc.'s listed patents on Allegra-D® Extended Release Tablets.
The FDA's acceptance of the ANDA for filing means that the agency has determined
that the application is sufficiently complete so as to permit a review.
``This is our eighth filing of an ANDA under Paragraph IV with the FDA, and
was our seventh filing in calendar year 2001,'' said Larry Hsu, Ph.D., President
and Chief Operating Officer. ``With this filing, we continue to advance the
pipeline of products that will drive our sales growth in the years to come.
Looking forward, we have set a goal of filing between six and eight new ANDAs
in 2002.''
IMPAX currently has fifteen ANDA filings pending at the FDA that address more
than $8 billion in U.S. branded product sales. Nine 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. IMPAX markets its generic products through its Global Pharmaceuticals
division and intends to market its branded products through the IMPAX Pharmaceuticals
division. 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: www.impaxlabs.com.