FDA approves first 3 generics of Gilenya

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FDA approves first 3 generics of Gilenya

By Sandra Levy - 12/06/2019

HEC Pharm, Biocon, and Sun Pharmaceutical Industries have received the Food and Drug Administration’s nod for first generics of Novartis' Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis, or MS in adult patients.

"Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA," said Janet Woodcock, 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."


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