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www.fdanews.com/articles/70355-teva-gets-tentative-approval-to-copy-pfizer-s-norvasc

Teva Gets Tentative Approval to Copy Pfizer's Norvasc

March 28, 2005

Teva Pharmaceutical Industries Ltd., the world's biggest generic-drug maker, said its version of Pfizer's blood-pressure medicine Norvasc received tentative approval from the US FDA, according to a report from Bloomberg.

Teva expects to get final permission to sell tablets containing the drug's active ingredient, amlodipine besylate, when Pfizer's patent expires Sept. 25, 2007, the Israel-based company said in a statement.

Norvasc, which is used to treat hypertension and angina, had sales of about $2.4 billion last year for Pfizer, the world's biggest drugmaker. The FDA's tentative approval of the generic product covers doses of 2.5 milligrams, 5 milligrams and 10 milligrams, Teva said.

Teva shares rose 4.50 shekels, or 3.5 percent, to 134.50 shekels, at 1:22 p.m. in Tel Aviv trading.