Arpida Files NDA for Skin Infections Drug
Posted on: Wednesday, 19 March 2008, 09:00 CDT
Biopharmaceutical Arpida has submitted a new drug application for intravenous iclaprim for the treatment of complicated skin and skin structure infections to the FDA.
Arpida has requested a priority designation for the review of the new drug application (NDA). The iclaprim NDA contains data from 15 clinical studies, including two adequate and well-controlled multinational pivotal Phase III trials (Assist-1 and Assist-2, in which approximately 1,000 patients were enrolled and treated).
Khalid Islam, president and CEO of Arpida, said: "Arpida has successfully progressed iclaprim from an early preclinical stage all the way to regulatory filing. We look forward to working closely with the FDA on their review of our submission."
Source: Datamonitor
Related Articles
- Pfizer: Withdraws Zeven Marketing Applications
- Arpida's Iclaprim MAA Accepted for Review By European Medicines Agency
- Arpida's Iclaprim MAA Accepted for Review By EMEA
- FDA Accepts Arpida's Iclaprim NDA
- Astellas/Theravance: FDA Delays Telavancin Approval
- Arpida Presents Additional Data on Iclaprim at IDSA
- Arpida Presents Preclinical and Clinical Data on Iclaprim at ICAAC
- Arpida Reports Positive Results of Second Pivotal Phase III Trial With Intravenous Iclaprim in cSSSI
- Targanta Therapeutics: IPO Based on Oritavancin
- Astellas Pharma: Telavancin Enters EU Battle for MRSA Market Share
 |
 |
User Comments (0)
RSS Feeds