Date: 2012-03-26
Type of information:
Product name: R-baclofen
Compound: R-baclofen
Therapeutic area:
Action mechanism:
Company: Lakeside Regulatory Consulting Services Ltd (UK)
Disease: fragile X syndrome
Latest news: * On January 11-12, 2011, the Committee for Orphan Medicinal Products (COMP) adopted a positive opinion recommending R-baclofen for treatment of fragile X syndrome, for designation as orphan medicinal products to the European Commission.
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:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2008-11-28
Orphan status UE: 2011-04-15
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
