Canadian pharmaceutical company Apotex Inc announced on Friday that its US subsidiary Apotex Corp has received the first US Food and Drug Administration (FDA) tentative approval for its Abbreviated New Drug Application (ANDA) for Semaglutide Injection, marking a milestone in expanding affordable access to complex peptide therapies for patients across the United States.

The product is a generic version of Ozempic, a weekly injection prescribed to treat type 2 diabetes by managing blood sugar levels.

Developed through a strategic partnership with India-based Orbicular Pharmaceutical Technologies, Apotex says that the Semaglutide Injection programme is a result of sophisticated development capabilities, including advanced analytical characterisation and deep process understanding.

Upon becoming eligible for final approval, Apotex's Semaglutide Injection is expected to help broaden patient access to an important therapy area where affordability and availability remain critical.