Jubilant’s US subsidiary wins FDA approval for generic Sestamibi

Indian pharmaceutical company Jubilant Organosys has reported that its subsidiary in the US, Draximage has received FDA approval for the company’s abbreviated new drug application for generic Sestamibi. The product is found to be bioequivalent and therapeutically equivalent to reference listed drug Cardiolite.

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.

Jubilant, through its subsidiary in the US, has an exclusive distribution agreement with GE Healthcare to distribute and sell Draximage’s generic Sestamibi through GE Healthcare’s nuclear pharmacy network in the US.

According to Jubilant, Draximage Sestamibi is the only generic Tc-99m for MPI, to be marketed by GE. The initial term of the distribution agreement is for a minimum of three years post approvals and the product is expected to be launched shortly.

Shyam Bhartia, chairman, and Hari Bhartia, co-chairman of Jubilant Organosys, said: We are very excited to receive the FDA approval of one of our key radiopharma products which strengthens our position in this business. We are ready to launch Draximage Sestamibi in the market and will see a steady flow of revenues from this product from the first quarter of financial year 2010. As we are the second generic player in the market and there is very limited competition, we expect moderate price erosion for this product.