May 28, 2003 -- IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that
the United States Food and Drug Administration (FDA) has accepted the Company's
filing of an Abbreviated New Drug Application (ANDA) for a generic version of
Wellbutrin SR® (Bupropion Hydrochloride) 200mg Tablets. GlaxoSmithKline
(Glaxo) markets Wellbutrin SR® for the treatment of depression. U.S. sales
of Wellbutrin SR® 200mg Tablets were approximately $46 million in the twelve
months ended December 31, 2002, according to IMS Health. Glaxo received FDA
approval of this product in June 2002.
IMPAX's application includes a certification under Paragraph IV of the
Hatch-Waxman Amendments stating the Company's belief that its Bupropion
Hydrochloride 200mg Extended Release Tablet product does not infringe certain
Glaxo listed patents on Wellbutrin SR® Tablets. FDA's acceptance of
the IMPAX ANDA for filing means that the Agency has made a threshold determination
that the application is sufficiently complete to permit a substantive review.
Larry Hsu, Ph.D., President of IMPAX, said, “This application complements
our previous ANDAs for Bupropion HCl 100mg and 150mg Extended Release Tablets.
We expect to reach our objective of filing six new applications in 2003.”
IMPAX has twenty ANDAs pending at the FDA, including three tentatively approved,
that address more than $6.4 billion in U.S. branded product sales for the twelve
months ended December 31, 2002. Fifteen 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: www.impaxlabs.com.