Concord Biotech Secures Abbreviated New Drug Application (ANDA) Approval for Tofacitinib Tablets, 5 mg and 10 mg
CONCORDBIO · price
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Concord Biotech has received approval for its Abbreviated New Drug Application (ANDA) from the US FDA for Tofacitinib Tablets in 5 mg and 10 mg strengths. Tofacitinib is used to treat rheumatoid arthritis and other autoimmune conditions. This generic approval allows Concord to manufacture and market the drug in the US, competing with Pfizer's branded version Xeljanz. The approval expands the company's regulated market portfolio, particularly in the lucrative US generics space.
This is a positive development as it opens a new revenue stream from the US market. However, near-term financial impact may be modest given typical ANDA launch timelines and competitive pricing pressure in the US generics market.