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# Mylan Urges Faster ANDA Approval for MS Generic
- URL: https://www.fdaweb.com/mylan-urges-faster-anda-approval-for-ms-generic/
- Published: 2020-06-19T12:00:00.000Z
- Updated: 2026-09-14T16:18:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147047

Mylan says it is urging FDA to speed up its review of the company’s ANDA for a generic copy of Biogen’s multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate) delayed release capsules, following a 6/18 northern West Virginia federal court decision that invalidated a Biogen patent. The current regulatory approval target action date is 11/16, according to Mylan CEO **Heather Bresch**. “Once approved and launched, we believe our generic Tecfidera will potentially be the first generic of any MS treatment in an oral solid dosage form available to patients in the U.S., further advancing our commitment to provide a broad portfolio of central nervous system medicines, which already includes glatiramer acetate injection,” she says.

Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for a dimethyl fumarate product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final approval. Annual sales of Biogen’s Tecfidera is about $3.8 billion.