This is the agency’s first generic approvals of Gilenya.
FDA granted approval to the first generics of fingolimod (Gilenya, Novartis) capsules to treat relapsing forms of multiple sclerosis (MS).
FDA cleared the generic fingolimod applications to HEC Pharm Co. Limited, Biocon Limited, and Sun Pharmaceutical Industries Limited.
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The approval signals a potential windfall for the pharma makers, since Novartis reported $2.4 billion in sales of Gilenya for the first nine months of this year.
Novartis previously filed several lawsuits attempting to block generic competition to Gilenya.
“Having access to affordable treatments is important for patients with conditions that require ongoing care. The FDA has a longstanding commitment to increasing patient access to lower-cost, high-quality generic medicines,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, in a statement from FDA.
Fingolimod must be dispensed with a Medication Guide that includes risks such as slowing of the heart rate, especially after the first dose. Because fingolimod may increase the risk of serious infections, patients should also be monitored for infection during treatment and for 2 months after discontinuation of treatment, FDA said.
A rare brain infection that usually leads to death or severe disability, called progressive multifocal leukoencephalopathy has been reported in patients being treated with the drug, according to FDA. Other serious risks include respiratory problems, liver injury, increased blood pressure, and skin cancer.
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