Pharmaceutical Benefits Scheme
Certain medications listed on the PBS are available only for specific therapeutic indications or to patients meeting specific criteria where the PBAC has deemed that the cost-benefit analysis is favourable only in those indications/patients. These are noted as "restricted benefits" on the Schedule. Medicare Australia places the onus of policing restricted benefits on the prescribers themselves and the pharmacists dispensing (unless the listing is also 'Authority Required'). For example, the COX-2 inhibitor celecoxib is listed on the PBS as a restricted benefit for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. Prescribers using celecoxib for other indications are expected to indicate "non-PBS" on the prescription, and/or the pharmacist dispensing the celecoxib should charge the patient the full cost.
Anecortave acetate
Retaane (15 mg anecortave acetate depot suspension) which is manufactured by Alcon, Inc., was a fast track designated product which was also a drug in FDA’s Pilot Continuous Marketing Application (CMA) program which often enrolls drugs which are being brought to the market and have an indication for a significant unmet medical need. This allowed Retaane to file with the FDA using a “rolling” New Drug Application, which allows specific units, Chemistry, Manufacturing, and Controls (CMC), pre-clinical, and the clinical unit, of the NDA to be reviewed as they are completed instead of as one large document. This allows the FDA to review each unit within six months of the submission. Alcon first filed the CMC unit in 2003, the Pre-clinical and Clinical units in 2004. In 2005 Alcon, Inc. announced they received the approval letter for the NDA for Retaane.