Teva Pharmaceutical Industries Ltd (TEVA)

[genisi]

Teva ordered to halt generic Lotrel despite FDA's OK

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070520:MTFH79118_2...

Sun May 20, 2007 9:42 AM ET

JERUSALEM, May 20 (Reuters) - Israel-based Teva Pharmaceutical Industries <TEVA.O> <TEVA.TA> said on Sunday it had received final U.S. Food and Drug Administration approval to sell a generic version of Novartis's <NOVN.VX> drug Lotrel.

However Teva, the world's largest generic drugmaker, said in a statement that a U.S. court had then granted an emergency request made by the Swiss-based firm Novartis for Teva to halt shipments of the drug that treats high blood pressure on the grounds of patent infringement.

Annual sales of Lotrel are about $1.5 billion a year, Teva said citing IMS sales data.

Teva said it had received the FDA approval on Friday for its amlodipine besylate/benazepril products in 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg amd 10 mg/20 mg dosage strengths and it immediately began shipments.

Teva had been awarded 180 days exclusivity for the products.

But on Saturday the United States District Court in New Jersey granted Novartis an emergency request for a temporary order restraining Teva's launch.

A hearing on the matter is scheduled for Monday at 11 am ET (1500 GMT).