Skip to main content

nebivolol

Generic: NEBIVOLOL HYDROCHLORIDE·Brand: BYSTOLIC, Bystolic, Byvalson, NEBIVOLOL HYDROCHLORIDE

nebivolol: developed by 2 companies · 2 FDA decisions.

nebivolol evidence translation

What we can confirm

2 FDA records

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

What is verified about nebivolol, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

Development Pipeline (2)
CompanyPhase
Allergan plc (AGN)Approved
ANI PHARMACEUTICALS INC (ANIP)Approved
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE Nebivolol Tablets are a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) 1.1 Hypertension Nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ( 14.1 )] . Nebivolol tablets may be used alone or in combination with other anti(ANIP)FDA ↗
ANDA203659UNKNOWNOralTablet
Approval1. INDICATIONS AND USAGE BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) 1.1 Hypertension BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ( 14.1 )]. BYSTOLIC may be used alone or in combination with other antihypertensive agents [see Drug(AGN)FDA ↗
NDA021742Type 1 - New Molecular EntityStandardOralTablet

Frequently asked questions

Who is developing nebivolol?

nebivolol is being developed by Allergan plc, ANI PHARMACEUTICALS INC.

What is nebivolol's latest FDA decision?

The most recent tracked FDA decision for nebivolol is Approval for 1 INDICATIONS AND USAGE Nebivolol Tablets are a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) 1.1 Hypertension Nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ( 14.1 )] . Nebivolol tablets may be used alone or in combination with other anti, dated April 16, 2015.