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US FDA approves generic versions of Novartis blockbuster MS treatment

expresspharmaDecember 09, 2019

Tag: FDA , Novartis , MS treatment

The US Food and Drug Administration approved three generic versions of Swiss drugmaker Novartis AG’s top-selling multiple sclerosis (MS) medicine Gilenya.

The approval allows HEC Pharm Co, Biocon and Sun Pharmaceutical Industries to produce the drug for the treatment of relapsing forms of MS in adult patients.

Novartis was defending patents on Gilenya in the United States to block generic rivals.

Earlier in June, US federal court order had prevented rival generic makers from selling versions of Gilenya in the United States.

Nearly a decade after its US approval, Gilenya remains Novartis’s number two revenue generator at $829 million in the third quarter.

Previous:ImCheck raises Series B funds to develop gamma delta therapies

Next:FDA approves first generics of Gilenya

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