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  • Orphan drug 'Thio Spal-P' avoids approval cancellation
  • by Kim, Jin-Gu | translator Hong, Ji Yeon | Apr 15, 2025 05:55am
Seoul Administrative Court ruled in favor of Dongin Pharm's suit, arguing about 'the cancellation measure of imported product approval is wrongful'
Multiple reversals of suspension of reimbursement¡¦MFDS' measure was nullified after a year-long suit
A rare disease treatment, 'Thio Spal-P Inj (thiotepa),' faced narrow escape from receiving approval cancellation.

According to pharmaceutical industry sources on the 11th, the Seoul Administrative Court ruled in favor of Dongin Pharm against the Ministry of Food and Drug Safety (MFDS), ruling a 'plaintiff victory' on the 10th.

Dongin Pharm filed a suit in the administrative court arguing that the MFDS' administrative measure related to the cancelation of imported item approval in May last year.

This rare disease treatment is used as a premedication regimen before autologous¡¤allogenic stem cell transplantation in adult¡¤pediatric patients with hematological diseases. It is also used when high-dose chemothera
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