FDA approves generics of multiple sclerosis Rx
Note: this article is provided by ONU Healthwise Pharmacy.
The US Food and Drug Administration (FDA) has approved generic versions of Gilenya, a multiple sclerosis (MS) medication.
Gilenya (fingolimod) is used to treat adults with relapsing forms of MS. This medication is available in capsule form. The FDA initially approved this drug in 2010, but it has only been available as a brand-name medication — until now.
This month, the FDA approved three applications for generic Gilenya. A generic version means a more affordable treatment option.
MS is a nervous system disease that affects your brain and spinal cord. It interrupts the communication between your brain and body, which leads to symptoms like muscle weakness and trouble with coordination and balance.
This medication must be dispensed with a medication guide. This informational packet explains the risks. Serious risks tied to fingolimod include possible slowing of the heart rate, serious infections and liver injury.
The FDA granted the approvals of the generic versions to three companies: HEC Pharm Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited.
Speak with your health care provider if you have any questions.
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