FDA Approves New Generic for Adults With MS

Three applications for first generics of Gilenya (fingolimod) capsules have been approved by the US Food and Drug Administration for the treatment of relapsing forms of multiple sclerosis (MS) in adults.

Approvals of generic fingolimod applications were granted to HEC Pharm Co. Limited, Biocon Limited, and Sun Pharmaceutical Industries Limited.

“Approving safe and effective generics so [that] patients have more treatment options continues to be a priority for the FDA,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “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.”

—Amanda Balbi


FDA approves first generics of Gilenya [press release]. Silver Spring, MD: US Food and Drug Administration; December 5, 2019.