Agência Nacional de Vigilância Sanitária (Anvisa)

Is Exenatide legal in Brazil?

Not approvedNo active registration: the Byetta and Bydureon registrations show as inactive in Anvisa's register

Not approved as a medicine here.

Anvisa's register lists Byetta (registered from 2007) and Bydureon (2017) entries under Eli Lilly, Bristol-Myers Squibb and AstraZeneca, but all show status 'Inativo'. That means no current marketing authorisation. Because it has no active registration, exenatide cannot be marketed in Brazil today. Lixisenatide, a related drug, is covered by RDC 973/2025 through the Soliqua registration.

Last verified 2026-09-29 · how we verify

Exenatide elsewhere

Sources (2)

  1. 01Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)Agência Nacional de Vigilância Sanitária (Anvisa) · 2026-09-29 · accessed 2026-09-29
  2. 02Anvisa estabelece novas regras para prescrição e dispensação de medicamentos agonistas de GLP-1Conselho Federal de Farmácia (CFF) · 2026-01-16 · accessed 2026-09-29