Jubilant Organosys Ltd, an integrated pharmaceutical industry player, has notified that its US subsidiary, DRAXIMAGE LLC has received the US Food and Drug Administration approval for the company’s Abbreviated New Drug Application (ANDA) for Draximage’s generic Sestamibi.
Draximage Sestamibi, is a generic kit used in the preparation of Technetium (Tc-99m) Sestamibi injection – a diagnostic cardiac imaging agent used in Myocardial Perfusion Imaging (MPI), to evaluate the flow of blood to the heart.
The product is found to be bioequivalent and therapeutically equivalent to reference listed drug Cardiolite. The market size of the drug is currently estimated at $400 million.
It should be noted that Jubilant’s subsidiary in the US, has an exclusive distribution agreement with GE Healthcare to distribute and sell generic Sestamibi through GE Healthcare’s nuclear pharmacy network in the US.
Market experts believe that The Draximage’s generic Sestamibi USFDA approval is a significant milestone for the Company’s radiopharma business.