Mar 4, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that its U.S. subsidiary has filed a lawsuit against the U.S. Food and Drug Administration ("FDA") seeking an order requiring the FDA to relist in the Orange Book U.S. Patent No. 5,158,952 and grant Teva 180-day exclusivity for a generic version of Janssen Pharmaceutical's Risperdal(R) (Risperidone) Tablets.
Teva argues that the FDA's denial of Teva's Citizen's Petition, seeking the relisting of U.S. Patent No. 5,158,952 and restoration of Teva's 180-day exclusivity for its pending abbreviated new drug application for risperidone tablets, was unlawful, as Teva disputes that the agency provided legal notice that the patent had been delisted prior to Teva's submission of a Paragraph IV certification to that patent.
No comments:
Post a Comment