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OPFOLDA (NDA215211)- (65MG)

MIGLUSTAT AMICUS THERAP US
65MG
No No
2037-Aug-12 Expired
None 2026-Sep-28
None No
OPFOLDA is an enzyme stabilizer indicated, in combination with Pombiliti, a hydrolytic lysosomal glycogen-specific enzyme, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT).
0 0 0
Total Other Developers None
Drugs with Suitability No
65MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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