Date: 2016-12-13
Type of information: Granting of the orphan status in the US
Product name: 3-aminopropyl-butyl phosphinic acid
Compound: 3-aminopropyl-butyl phosphinic acid
Therapeutic area: Rare diseases - Neurological diseases
Action mechanism:
Company: Speragen (USA - TX)
Disease: succinic semialdehyde dehydrogenase deficiency
Latest news: * On December 13, 2016, the FDA has granted orphan drug designation for 3-aminopropyl-butyl phosphinic acid for the treatment of succinic semialdehyde dehydrogenase deficiency.
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: 2016-12-13
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
