Teva gets tentative OK for generic Prinivil

23 April 2001

Teva Pharmaceuticals of Israel has announced that the US Food and DrugAdministration has awarded tentative approval for 10mg/12.5mg, 20mg/12.5mg and 20mg/25 tablets of lisinopril/hydrochlorothiazide, a generic equivalent of Merck & Co's Prinivil, for the treatment of hypertension.

Teva expects to get final FDA approval when Merck's patent for Prinvil expires at the end of the year. However, Merck spokeswoman Gwen Fisher said that her firm is conducting pediatric trials of Prinivil that might allow Merck to win a six-month extension of the medicine's US marketing exclusivity.

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