IMPAX's Second Tentative Approval of a Paragraph IV ANDA Filing
May 29, 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® 24-Hour (loratadine/pseudoephedrine sulfate, 10mg/240mg)
Extended Release Tablets.
Claritin-D® 24-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 of the tablets were approximately $539 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;
and the expiration of any generic marketing exclusivity. 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, 10mg/240mg
(24-hour formulation) in November 2000 and commented on the filing of a lawsuit
by Schering Corporation alleging patent infringement relating to the ANDA in
January 2001.
"We are very pleased to receive this notification for Loratadine and Pseudoephedrine
Sulfate Extended Release Tablets, 10mg/240mg (24-hour formulation), our second
tentative approval of an ANDA containing a Paragraph IV certification,"
said Larry Hsu, Ph.D., President and Chief Operating Officer. "We continue
to make progress both in submitting new ANDAs, as well as in moving our pending
ANDAs through the FDA review process toward commercialization."
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 two 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.