Topics for Discussion

1
Topics for Discussion

• Please discuss the extent to which you believe
  the criteria established in 21 CFR 2.125 for
  removal of a drug substance from the list of
  essential uses for CFCs have been met for
  albuterol. These criteria are
• At least 2 non-ozone depleting substances
  (non-ODS) that contain the same active moiety are
  being marketed with the same route of delivery,
  for the same indication, and with approximately
  the same level of convenience of use as the
  ozone-depleting products
• Supplies and production capacity for the non-ODS
  products exist or will exist at levels sufficient
  to meet patient need
• Adequate US post-marketing use data is available
  for the non-ODS products
• Patients who medically require the ODS product
  are adequately served by the non-ODS products
  containing the active moiety and other available
  products
• Please suggest any additional data or information
  you believe would be important to consider in
  making a determination regarding the essential
  use status of albuterol.
• Please comment on any additional issues you
  believe would be important to consider in making
  a determination regarding the essential use
  status of albuterol.