On August 8, 2023, U.S. Food and Drug Administration（FDA）tentatively approved SinoT’s ANDA application for Tofacitinib Extended Release Tablet (ANDA #216001).
Tofacitinib is a type of medicine known as a Janus kinase (JAK) inhibitor. It works by blocking the action of Janus kinase enzymes, which are involved in the inflammation that causes the symptoms of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polyarticular course juvenile idiopathic arthritis, and ulcerative colitis
SinoT is a specialty pharma with focus on the research & development, commercialization and sale of complex generics and 505(b2) products. We dedicated to developing high quality medicines that meet with international standards. We’ll do more than our best to benefit the patients in the future.