SAN FRANCISCO (Thomson Financial) - Endo Pharmaceuticals Inc., a subsidiary
of Endo Pharmaceuticals Holdings Inc., and Penwest Pharmaceuticals Co. late
Friday said they have filed a lawsuit against Hayward, Calif.-based
pharmaceutical firm Impax Laboratories Inc. in connection with Impax's
abbreviated new drug application for a generic version of Opana ER
extended-release tablets CII, an opioid analgesic for post-operative pain.
The lawsuit, filed in the U.S. District Court for the District of Delaware,
is in response to Impax's letter advising Endo and Penwest that the Food and
Drug Adminstration has accepted for substantive review Impax's abbreviated new
drug application concerning oxymorphone hydrochloride extended-release tablets
CII.
Chadds Ford, Pa.-based Endo and the Danbury, Conn.-based Penwest are
alleging infringement of patents relating to the formulation of Opana ER.
The two pharmaceutical companies said Opana ER has been granted new dosage
form regulatory exclusivity that prevents the FDA from approving any abbreviated
new drug application for a generic version of Opana ER for launch prior to June
22, 2009.
Endo shares closed the regular session up 21 cents at $24.87. Penwest shares
fell 8.5% to close at $3.45, and 5% in after-hours trading.
Brigid Gaffikin
bg/gm
COPYRIGHT
Copyright Thomson Financial News Limited 2007. All rights reserved.
The copying, republication or redistribution of Thomson Financial News Content,
including by framing or similar means, is expressly prohibited without the prior
written consent of Thomson Financial News.
|