The company stated that it is likely to submit dosing schedule updates for an additional approved indication
to the regulator in the future.
Dosing schedule updates for an additional approved indication
for Opdivo may be submitted to the FDA in the future.
Food and Drug Administration (FDA) approval for an expanded age indication to include adults 18 through 49 years of age, in addition to the already approved indication
for adults 50 years and older, for active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumoniae (S.
The approved indication
for the fibrin sealant is for use with an absorbable gelatin sponge; it is the first spray-dried fibrin sealant approved by the FDA, according to its statement.
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
Dronedarone (Multaq), a benzofuran derivative that is an analogue of amiodarone, is approved in the United States and the European Union for a different population of patients with AF, not those with permanent AF, and "the benefit-risk of Multaq remains unchanged in its approved indication
in nonpermanent AF," the company said in a press release.
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.
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.
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.
This board will focus primarily on physician education and community awareness regarding the importance and availability of solutions for neglected comorbidities, such as the first-in-class anti-secretory mechanism of action of Mytesi for its currently approved indication
The previously approved indication
of Macular Edema secondary to CRVO was based on data from the Phase 3 COPERNICUS and GALILEO studies.