Public record

Rare Pediatric Disease designation.

FDA grant letter for designation request RPD-2025-1146. Clemastine fumarate is designated for the treatment of Pelizaeus-Merzbacher disease as a drug for a rare pediatric disease. The letter is addressed to MGAM LLC, a subsidiary of Elovaren LLC.

Page 1 of the FDA letter granting rare pediatric disease designation request RPD-2025-1146. Clemastine fumarate is designated for treatment of Pelizaeus-Merzbacher disease. The letter is addressed to MGAM LLC.
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Page 2 of the FDA rare pediatric disease designation letter to MGAM LLC, setting out the statutory criteria for a rare pediatric disease product application.
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Page 3 of the FDA rare pediatric disease designation letter to MGAM LLC, signed for the Office of Orphan Products Development and the Office of Pediatric Therapeutics.
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