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Frontier Bio: FB4001 has submitted an ANDA registration application to the U.S. FDA and has passed the FDA's on-site inspection with zero deficiencies before approval.
Ask AI · How will FB4001 break into the osteoporosis treatment market?
On March 19, Frontier Bio stated on an interactive platform that the company’s FB4001 (teriparatide injection generic drug for the treatment of osteoporosis) has submitted an ANDA registration application to the U.S. FDA and has passed the FDA’s pre-approval site inspection with zero defects. It is currently in the post-marketing research stage. The company is actively promoting subsequent work and will fulfill its information disclosure obligations in accordance with relevant regulations.