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Nebivolol and valsartan Approval Status

Nebivolol and Valsartan is an investigational fixed dose combination of well-established antihypertensive drugs for the treatment of hypertension.

In December 2014, Actavis plc announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for the fixed-dose combination (FDC) of nebivolol and valsartan had not been approved.

Development Status and FDA Approval Process for nebivolol and valsartan

Dec 24, 2014Actavis Confirms Complete Response Letter for Nebivolol/Valsartan Fixed-Dose Combination for Hypertension
Feb 27, 2014Forest Laboratories Submits NDA for Nebivolol and Valsartan Combination in Hypertension

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