Novartis' hypertension therapy Exforge has a likely user fee date of late December based on a standard 10-month review.

The firm announced April 27 that FDA had accepted the NDA for Exforge, a combination of its Diovan (valsartan) and amlodipine in a single daily dose.

The filing was based on Phase III clinical trial results involving more than 5,000 patients showing "powerful blood pressure control with excellent safety and tolerability," the firm said.

Novartis submitted Exforge for EU marketing authorization in March, the company said.

Novartis/Speedel's oral renin inhibitor Rasilez (aliskerin) is following a similar timeline at FDA, with approval possible by year-end (¹ Also see "Novartis/Speedel Anti-Hypertensive Rasilez Could Reach Market By Year-End" - Pink Sheet, 20 April, 2006.).

-Todd Leeuwenburgh

Novartis’ Exforge Has Late December User Fee Date

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