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FDA Approvals

Over the past 30+ years, CHeT has played a significant role in advancing medical innovation by supporting clinical studies that led to 12 FDA-approved treatments. Ten of these approvals were achieved through our Clinical Trials Coordination Center (CTCC), with an additional three supported by our Clinical Materials Services Unit (CMSU).

Very few potential treatments ever make it from the lab to patients. Each year, thousands of new compounds are studied, but only a small number move into clinical trials—and even fewer are approved by the FDA. Helping bring this many approved treatments to patients shows CHeT’s long-standing role in turning promising research into real care.


Pramipexole
 

Pramipexole

1997
Sponsor: Pharmacia & Upjohn
Disease: Parkinson's Disease
Brand Name: Mirapex

Entacapone
 

Entacapone

2003
Sponsor: Orion Corporation
Disease: Parkinson's Disease
Brand Name: Comtan


Selegiline
 

Selegiline

2006
Sponsor: Somerset Pharmaceuticals
Disease: Parkinson's Disease
Brand Name: Emsam

Rasagiline
 

Rasagiline

2006
Sponsor: Teva Pharmaceuticals
Disease: Parkinson's Disease
Brand Name: Azilect

Rotigotine
 

Rotigotine

2007
Sponsor: Schwarz Pharma
Disease: Parkinson's Disease
Brand Name: Neupro

Tetrabenazine
 

Tetrabenazine

2008
Sponsor: Prestwick Pharmaceuticals
Disease: Huntington's Disease
Brand Name: Xenazine

Dichlorphenamide
 

Dichlorphenamide

2015
Sponsor: Taro Pharma
Disease: Primary Hypokalemic & Primary Hyperkalemic Periodic Paralysis
Brand Name: Keveyis

Deutetrabenazine
 

Deutetrabenazine

2017
Sponsor: Teva Pharmaceuticals
Disease: Huntington's Disease
Brand Name: Austedo

Calcipotriene & Betamethasone Dipropionate
 

Calcipotriene & Betamethasone Dipropionate

2020
Sponsor: MC2 Therapeutics
Disease: Plaque Psoriasis
Brand Name: Wynzora

Polymyxin B-immobilized Fiber Column (Device)
 

Polymyxin B-immobilized Fiber Column (Device)

2022
Sponsor: Spectral Medical
Disease: Endotoxin in Bloodstream
Brand Name: PMX (Toraymykin PMX-20R)

Omaveloxolone
 

Omaveloxolone

2023
Sponsor: Reata Pharmaceuticals
Disease: Friedreich's Ataxia
Brand Name: Skyclarys

Valbenazine
 

Valbenazine

2023
Sponsor: Neurocrine Biosciences
Disease: Chorea for Huntington's Disease
Brand Name: Ingrezza