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ACTIVE SUBSTANCE / INN

PIRFENIDONE

Brand name(s): PIRFENIDONE, Pirfenidone Viatris, ESBRIET, Esbriet, Pirfenidone axunio (previously Pirfenidone AET)
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA022535
Idiopathic Pulmonary Fibrosis;Lung Diseases;Respiratory Trac…
ACTIVE SUBSTANCE
Pirfenidone
REGULATORS
FDA · EMA
SPONSORS / MAH
AMNEAL, LEGACY PHARMA, GRANULES INDIA
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PIRFENIDONEANDA212569AMNEALPrescription
PIRFENIDONEANDA212615GRANULES INDIANone (Tentative Approval)
ESBRIETNDA022535LEGACY PHARMAPrescription
ESBRIETNDA208780LEGACY PHARMADiscontinued
PIRFENIDONEANDA212403CHARTWELL RXDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Pirfenidone ViatrisViatris LimitedAuthorised10/01/2023Idiopathic Pulmonary Fibrosis;Lung Diseases;Respiratory Tract Diseases
EsbrietRoche Registration GmbHAuthorised27/02/2011Idiopathic Pulmonary Fibrosis;Lung Diseases;Respiratory Tract Diseases
Pirfenidone axunio (previously Pirfenidone AET)Axunio Pharma GmbHAuthorised20/06/2022Idiopathic Pulmonary Fibrosis

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