We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » ORPHAN DRUG STATUS GRANTED FOR SCD TREATMENT

ORPHAN DRUG STATUS GRANTED FOR SCD TREATMENT

June 14, 2006

Xechem International's new treatment for sickle cell disease (SCD) has been designated an orphan drug by the FDA, the company announced.

The drug, 5-HMF, is a five-membered heterocyclic anti-sickling compound that interacts specifically with intracellular hemoglobin without affecting other proteins in the body. It produces little or no toxicity, according to Xechem.

Xechem said it intends to submit the investigational new drug application for 5-HMF in the next several months.

Orphan drug status, given to treatments for diseases that affect fewer than 200,000 people in the U.S., provides certain incentives such as a waiver of filing fees, grants for clinical trials and seven years of marketing exclusivity.

KEYWORDS FDAnews Drug Daily Bulletin

Upcoming Events

  • 13Jul

    FDA Ad and Promo Enforcement Trends: Past, Present and Future

  • 27Jul

    Applying the Lessons of the Pandemic to Your Upcoming Trial

  • 28Jul

    EU-MDR’s Growing Pains: Are You Current with the Latest Developments?

  • 28Jul

    Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does

  • 02Aug

    Medical Device Cybersecurity: Understand the Latest Developments

  • 03Aug

    Pharmaceutical Process Validation: Best Practices for Success

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • FX Receives FDA Clearance for Its FX V135 Shoulder Arthroplasty Platform

  • FDA Recommends Modified COVID-19 Vaccine Boosters Adapted to Omicron BA.4 and BA.5 Subvariants

  • FDA Approves Foundation Medicine’s Companion Diagnostic for Genentech’s Rozlytrek

  • Novartis Pays $100 Million for Mallinckrodt’s Priority Review Voucher

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing