Nebivolol and valsartan Approval Status
- FDA approved: No
- Generic name: nebivolol and valsartan
- Company: Forest Laboratories, Inc.
- Treatment for: High Blood Pressure
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, 2014||Actavis Confirms Complete Response Letter for Nebivolol/Valsartan Fixed-Dose Combination for Hypertension|
|Feb 27, 2014||Forest Laboratories Submits NDA for Nebivolol and Valsartan Combination in Hypertension|
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