US FDA OK for Teva's generic Cozaar/Hyzaar, as authorised generic is announced
This article was originally published in Scrip
Executive Summary
The US FDA has granted final approval on to Teva Pharmaceutical Industries' generic versions of Merck & Co's antihypertensives Cozaar (losartan potassium) and Hyzaar (losartan plus hydrochlorothiazide) (each in three strengths) – the first generics of these products. In its approval letter, the regulator stated that Teva, as the first to submit a substantially complete ANDA containing a Paragraph IV certification for losartan, is eligible for 180 days exclusivity.