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

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

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

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

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

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

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

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

Calcipotriene & Betamethasone Dipropionate
2020
Sponsor: MC2 Therapeutics
Disease: Plaque Psoriasis
Brand Name: Wynzora

Polymyxin B-immobilized Fiber Column (Device)
2022
Sponsor: Spectral Medical
Disease: Endotoxin in Bloodstream
Brand Name: PMX (Toraymykin PMX-20R)

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

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