• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
Pediatric Labeling Date:  02/01/2008
Trade Name:  Asmanex Twisthaler 110mcg inhalation powder
Generic Name or Proper Name (*):  mometasone furoate
Indications Studied:  Maintenance treatment of asthma as prophylactic therapy in children 4 years of age and older
Label Changes Summary:  * Not indicated for relief of acute bronchospasm or in children less than 4 years of age * Clinical studies, including 52 week safety trial conducted in children 4  11 years of age * Pediatric dosing information provided * Child may not get the most benefit for 1 to 2 weeks or longer after starting treatment * New dosage form
Product Labeling:  Labeling  Opens a new window
Sponsor:  Schering Corporation
Therapeutic Category:  Antiasthmatic