Pharma Focus Europe

Ambio Secures FDA Approval for Generic Teriparatide Injection, Collaborates With Apotex on Forteo® Substitute

Saturday, December 02, 2023

Ambio, Inc., a forward-thinking biotech company specializing in the development of novel peptide drugs, biosimilars, bioequivalents, and other intricate generic drugs, announced today that the U.S. Food and Drug Administration (FDA) has approved a generic version of Forteo®1 (teriparatide injection) developed by Ambio. The marketing and sales of this generic version will be managed by Apotex.

Simrat Singh, President of Ambio, Inc., emphasized the company's global leadership in complex peptide development, highlighting advanced techniques in controlling synthetic impurities and expertise in developing precise analytical methods for thorough peptide characterization. Singh expressed enthusiasm, stating, "We are pleased that the teriparatide injection developed by Ambio has received FDA approval."

Chris Bai, Founder, Chairman of the Board, and Chief Executive Officer of Ambio, Inc., underscored the approval as validation of the company's expertise and technological innovation in complex generic drug development. Bai expressed satisfaction with the partnership with Apotex, enabling them to swiftly secure FDA approval and launch the product.

Kiran Krishnan, SVP of Global Regulatory Affairs at Apotex, reiterated the company's commitment to enhancing patient access to affordable complex generic drugs. Krishnan stated, "The launch of Teriparatide Injection reflects Apotex's continued focus on improving access for patients to affordable complex generic drugs," expressing confidence in the product's significance in enhancing the quality of life for Osteoporosis patients in the U.S.

Teriparatide Injection is presented as a single-patient-use pre-filled pen containing 250 mcg/mL, facilitating 28 daily doses of 20 mcg per pen. Further details on Warnings and Precautions, Adverse Reactions, Contraindications, and the Medication Guide can be found in the complete prescribing information.



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