The previously approved indication
of Macular Edema secondary to CRVO was based on data from the Phase 3 COPERNICUS and GALILEO studies.
The approved indication
is as monotherapy "in patients with deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.
At a meeting in December 2011, the majority of an FDA advisory panel voted that peginesatide had a favorable risk-benefit profile for the approved indication
The drug's only approved indication
is for the treatment of narcolepsy, a fairly uncommon condition.
Once a product receives FDA approval, the manufacturer can legally market the product for its approved indication
and begin to enjoy the profits from its sale.
The Food and Drug Administration has approved several generic formulations of ropinirole for the treatment of restless legs syndrome but not for Parkinson's disease, the other approved indication
for the drug.
What they're saying now is that to stay on the market or to come on the market you have to have an approved indication
, and to have an approved indication
you have to show safety and efficacy.
Under terms of the new approved indication
, the HeartMate SNAP-VE can be used to support patients with New York Heart Association Lclass IV end-stage left ventricular failure who have received optimal medical therapy for at least 60 of the last 90 days, have a life expectancy of l less than 2 years and are not candidates for cardiac transplantation.
MRI) that, even though applied for an approved indication
, are useless because of insufficient unit capacity or technical failings.
The final chapter develops scenarios for setting a higher price in a subsequently approved indication
, highlighting the key determinants of success.
Telaprevir's approved indication
is for treatment (in combination with peginterferon alfa and ribavirin) of genotype I chronic hepatitis C in adults "with compensated liver disease, including cirrhosis, who are [treatment naive] or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers.
The label for XerclearTM, that is the approved indication
text, is unique for a topical cold sore product in Europe: