Recently, Wanbang Biopharmaceuticals (hereinafter referred to as “Wanbang Biopharma”) received the ANDA PAS (Prior Approval Supplement) approval letter from U.S. Food and Drug Administration (FDA) for Leflunomide Tablets. It marks that the above mentioned pharmaceutical product manufactured by Wanbang Biopharma can enter into the US market.
Leflunomide is an isoxazole immuno-modulatory agent with anti-proliferative activity. Its mechanism of action is mainly to inhibit the activity of dihydroorotate dehydrogenase, thereby affecting the synthesis of pyrimidine in activated lymphocytes. Leflunomide Tablets are indicated for treatment of adults with active rheumatoid arthritis.
In 2018, Wanbang Biopharma initiated the project for the contract manufacturing of Leflunomide tablets from Fosun Pharma USA Inc. In May 2019, Wanbang Biopharma’s solid dosage forms production line passed the FDA GMP Site inspection with “Zero Defect”. The PAS application for Leflunomide tablets was submitted through the FDA Electronic Submissions Gateway (ESG) portal in August 2019 and received PAS approval letter on June 4, 2020.
The PAS approval from the USFDA marks a further step forward in the internationalization of Wanbang Biopharma. In the future, Wanbang Biopharma will continue to benchmark international top-class pharmaceutical companies, providing global patients with good quality, accessible and affordable medicines and services with higher international standards.