FDA Grants Orphan Drug Status to Marshall Edwards's Melanoma Drug
Posted on: Wednesday, 20 February 2008, 12:02 CST
Marshall Edwards has said that triphendiol has been granted orphan drug status by the FDA for treatment of Stage IIB through stage IV malignant melanoma.
A grant of orphan drug status provides seven years of market exclusivity for the orphan indication after approval by the FDA, as well as tax incentives, study design assistance, and eligibility for grant funding from the FDA during its development.
Alan Husband, group director of research for Marshall Edwards, said: "This grant of orphan drug status for a third indication, malignant melanoma, is a further indication of the viability of the development program for triphendiol as a multipotent anticancer agent."
Source: Datamonitor
Related Articles
- Cell Therapeutics Applies for European Orphan Drug Designation for Pixantrone in Aggressive Non-Hodgkin's Lymphoma (NHL)
- Keryx Biopharmaceuticals Receives Orphan-Drug Designation for KRX-0401 (Perifosine) for the Treatment of Multiple Myeloma
- Cystic Fibrosis - Orphan Drug Designation for Innovative Treatment Against Lung Infections by Axentis Pharma AG
- Jazz Pharmaceuticals, Inc. Announces Receipt of FDA Orphan Drug Designation for Recurrent Acute Repetitive Seizures Product Candidate
- Corcept Therapeutics Receives Orphan Drug Designation for CORLUX(R) Treatment of Cushing's Syndrome
- Aastrom Receives Orphan Drug Designation From FDA for Dilated Cardiomyopathy
- Gentium Receives Orphan Drug Designation From FDA for Defibrotide to Prevent Hepatic Veno-Occlusive Disease
- Isotechnika's Partner, Lux Biosciences, Receives Orphan Drug Designation for Ophthalmic Indications of ISA247
- Osiris Therapeutics Receives European Orphan Drug Designation for PROCHYMAL(TM)
- AmpliMed Receives Orphan Drug Designation for Amplimexon in the Treatment of Ovarian Cancer
 |
 |
User Comments (0)
RSS Feeds