Flovent Diskus Would Be Useful Option With Advair Diskus - FDA Cmte.
Executive Summary
Glaxo Wellcome's Flovent Diskus would be a useful option for titration in conjunction with the Advair Diskus, FDA's Pulmonary-Allergy Drugs Advisory Committee suggested at its Nov. 23 meeting.
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Glaxo Flovent Diskus
Fluticasone inhalational powder for Diskus delivery device will not be marketed until 2001, the company said following Sept. 29 approval of the product for maintenance of treatment of asthma as prophylactic therapy for patients four and above. The product is also indicated for patients requiring oral corticosteroid therapy for asthma. Fluticasone is currently marketed in a metered dose inhaler and in a Rotadisk dry powder inhaler. The Flovent Diskus NDA was submitted in March 1998 and has been "approvable" since March 31, 1999 (1"The Pink Sheet" Dec. 6, 1999, p. 8)
Glaxo Flovent Diskus
Fluticasone inhalational powder for Diskus delivery device will not be marketed until 2001, the company said following Sept. 29 approval of the product for maintenance of treatment of asthma as prophylactic therapy for patients four and above. The product is also indicated for patients requiring oral corticosteroid therapy for asthma. Fluticasone is currently marketed in a metered dose inhaler and in a Rotadisk dry powder inhaler. The Flovent Diskus NDA was submitted in March 1998 and has been "approvable" since March 31, 1999 (1"The Pink Sheet" Dec. 6, 1999, p. 8)
Glaxo Wellcome Advair Compliance To Be Studied Following Approval
Glaxo Wellcome plans to look for improved patient compliance with Advair Diskus compared to other asthma treatments in post-marketing studies.