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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:

Is general: Yes