Date: 2014-09-16
Type of information: Granting of a patent
Product name: humanized monoclonal antibodies hu1B7 and hu11E6
Compound: humanized monoclonal antibodies hu1B7 and hu11E6
Therapeutic area: Rare diseases - Infectious diseases
Action mechanism:
Company: Synthetic Biologics (USA - MD)
Disease: Bordetella pertussis infection
Latest news: * On September 11, 2014, the FDA has granted orphan drug designation for humanized monoclonal antibodies hu1B7 and hu11E6 for the treatment of Bordetella pertussis.
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: 2014-09-11
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
