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  • Approval of Pfizer¡¯s JAK inhibitor Xeljanz Srup imminent
  • by Lee, Hye-Kyung | translator Alice Kang | Jan 4, 2023 05:32am
MFDS completes safety and efficacy review... can also be prescribed in children weighing less than 40kg
Pfizer¡¯s JAK inhibitor ¡®Xeljanz Syrup (tofacitinib citrate) 1mg/mL¡¯ may soon receive marketing authorization in Korea.

According to industry sources on the 3rd, the Ministry of Food and Drug Safety completed the safety and efficacy review for the marketing authorization application Pfizer Korea submitted for Xeljanz Syrup.

Generally, items receive marketing authorization soon after MFDS completes the safety and efficacy review.

Three items, 5mg and 10mg strengths of ¡®Xeljanz Tab¡¯ and 11mg strength of ¡®Xeljanz XR,¡¯ which are tablet formulations, are currently approved in Korea.

The drug that completed the safety and efficacy review this time is a syrup formulation that can be used to treat polyarti
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