Betterchem
Health     Drug Information     DMFs     Portal     21CFR     Search     Site Map

 

                  CDER News Archive
[index page]

 
                                                                                  

July 7, 2004

  • FDA approves Technetium (99m Tc) Fanolesomab, NeutroSpec (murine monoclonal antibody to CD15)
    for the scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older.

  • New and Generic Drug Approvals
    • ChloraPrep One -Step 10.5- mL Applicators (2% chlorhexidine gluconate solution), Beckloff Associates, Labeling Revision
    • Rocaltrol (calcitriol) Capsules, Hoffmann-La Roche Inc., Labeling Revision
    • Rocaltrol (calcitriol) Oral Solution, Hoffmann-La Roche Inc., Labeling Revision
  • Tentative Advisory Committee Meetings, CDER (updated)

July 6, 2004

  • New and Generic Drug Approvals
    • Noritate (metronidazole cream) Cream, Dermik Laboratories, Package Change
    • REYATAZ (atazanavir) tablets, Bristol-Myers Squibb, New Dosage Regimen
    • Technetium (99m Tc) Fanolesomab, NeutroSpec (murine monoclonal antibody to CD15), Palatin Technologies, Inc., Approval

<- Earlier

 
                                                                                  

© 2009 Betterchem.com