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# FDA Approves 3 ANDAs for Generic MS Drug
- URL: https://www.fdaweb.com/fda-approves-3-andas-for-generic-ms-drug/
- Published: 2019-12-05T12:00:00.000Z
- Updated: 2026-09-14T15:55:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145664

FDA has approved three ANDAs for the first generics of Novartis’ Gilenya (fingolimod) capsules for treating relapsing forms of multiple sclerosis in adult patients. Approvals were granted to HEC Pharm Co., Biocon Limited and Sun Pharmaceutical Industries.

An [FDA release](http://s2027422842.t.en25.com/e/es?s=2027422842&e=281853&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=122e5f9af0d54d6e915dc683daa120ec&elqaid=10519&elqat=1&ref=fdaweb.com) says that fingolimod must be dispensed with a Medication Guide that contains important information about its uses and risks. “Serious risks include slowing of the heart rate, especially after the first dose. Fingolimod may increase the risk of serious infections,” the agency says. “Patients should be monitored for infection during treatment and for two months after discontinuation of treatment. A rare brain infection that usually leads to death or severe disability, called progressive multifocal leukoencephalopathy (PML) has been reported in patients being treated with the drug. PML cases usually occur in patients with weakened immune systems.”