The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)
The product will be launched in March 2024
According to IQVIA sales data for the 12-month period ending September 2022, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately US $1.8 billion
Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis
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