The FDA approved Dec. 5 three applications for the first generic versions of Gilenya, Novartis' drug designed to treat adults with relapsing forms of multiple sclerosis.
The approvals were granted to HEC Pharm, Biocon and Sun Pharmaceutical.
MS is a chronic, inflammatory autoimmune disease that disrupts communication between the brain and other parts of the body.
The most common side effects of Gilenya are headache, elevated liver enzymes, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain and pain in the extremities.
The drug also comes with some serious risks, including slowed heart rate — especially after the first dose — serious infection, vision problems, swelling or narrowing of blood vessels in the brain, respiratory problems, liver injury or skin cancer.
It could also harm developing fetuses, so women taking Gilenya or generic versions are advised to use effective contraception.
Patients should be monitored for serious infection during treatment and for two months after discontinuing treatment.
Read the full news release here.
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