IMPAX's Third Tentative Approval of a Paragraph IV ANDA Filing
May 30, 2002 -- IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced
that the U.S. Food and Drug Administration (FDA) has granted tentative approval
to the Company's Abbreviated New Drug Application (ANDA) for a generic version
of Claritin-D® 12-Hour (loratadine/pseudoephedrine sulfate, 5mg/120mg) Extended
Release Tablets.
Claritin-D® 12-Hour is marketed by Schering-Plough Corporation for the
relief of symptoms of seasonal allergic rhinitis (hay fever). According to IMS
Health, U.S. sales were approximately $386 million for the twelve months ended
March 31, 2002.
Final approval is contingent upon the earlier of (1) the resolution of pending
patent-infringement litigation brought by Schering-Plough against IMPAX, or
(2) the expiration of the 30-month stay process under the Hatch-Waxman Amendments.
Final approval is also dependent upon FDA's evaluation of any new information
subsequent to this tentative approval.
IMPAX Laboratories announced FDA acceptance of the Company's ANDA filing for
Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 5mg/120mg (12-hour
formulation) in January 2001 and commented on the filing of a lawsuit by Schering
Corporation alleging patent infringement relating to the ANDA in February 2001.
"We believe we were the first to file an application for the 12-hour formulation
of generic Claritin with the FDA under Paragraph IV of the Hatch-Waxman amendments,"
said Larry Hsu, Ph.D., President and Chief Operating Officer of IMPAX Laboratories.
"This is our third tentative ANDA approval containing a Paragraph IV certification,
following the announcement of our second one, for Loratadine and Pseudoephedrine
Sulfate Extended Release Tablets, 10mg/240mg (24-hour formulation), earlier
this week. We are very pleased to have tentative approvals for two Claritin
formulations."
IMPAX currently has 15 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, and three of these now have tentative
approval from FDA.
IMPAX Laboratories, Inc. is a technology focused 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.