Date: 2011-12-19
Type of information: Granting of a Market Authorisation in the US
Product name: Bydureon®
Compound: exenatide
Therapeutic area: Metabolic diseases
Action mechanism: glucagon-like peptide-1 (GLP-1) receptor agonist
Company: Alkermes (USA-Ireland) Amylin Pharmaceuticals (USA) Eli Lilly (USA)
Disease: type-2 diabetes in adults
Latest news:
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2012-01-27
UE authorization: 2011-06-21
Favourable opinion UE: 2011-04-14
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
