Date: 2012-04-04
Type of information: Granting of the orphan status in the EU
Product name: clonidine Lauriad®
Compound: clonidine
Therapeutic area: Cancer - Oncology
Action mechanism:
Company: BioAlliance Pharma (France)
Disease: prevention of radiotherapy-induced oral mucositis in patients with head and neck cancer.
Latest news: * On June 24, 2011, BioAlliance Pharma announced the submission to the European (EMA) and American (FDA) Drug Agencies of an application for orphan medicinal product designation for clonidine Lauriad™, in the prevention of radiotherapy-induced oral mucositis in patients with head and neck cancer. Clonidine Lauriad™, presently in phase II clinical trial in Europe, is dedicated to the prevention of oral mucositis, a debilitating inflammation of the oral mucosa possibly altering the general condition of patients with head and neck cancer treated with radiotherapy and radio- and chemotherapy.
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:
Orphan status UE: 2011-11-02
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
