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On August 27th, Qilu Pharmaceuticals' application for the listing of -acid tofatab slow-release tablets filed by Qilu Pharmaceuticals under class 3 generics was accepted by CDE.
is a JAK inhibitor developed by Pfizer and has been approved worldwide for rheumatoid arthritis, ulcerative colitis and psoriasis arthritis.
Pfizer has developed tofatib tablets and slow-release tablets, among which the tablets were approved by the FDA in November 2012 under the name Xeljanz, 2 times a day or oral; Approved by the FDA in December 19 for the treatment of moderate to severe active ulcerative colitis in adult patients, the product is called Xeljanz XR, sizes 11 and 12 mg, oral 1 time per day.
Pfizer acid tofatisa tablets were approved for entry into China in March 2017 and are now in the national health insurance Category B catalogue and the third batch of collected drugs.
May 2020, Pfizer filed ain China for the release of the tyro-acid tofatab tablet, which is in the "review" phase.
Pharmaceuticals was the first manufacturer to submit a generic drug for the slow-release tablet.
addition, Stone Pharmaceutical Group's BE clinical treatment for this dosage form is under way.
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