FDA confirms transfer of ownership of 23 generic drugs to IDT Australia

The US Food and Drug Administration has confirmed receipt of the change of ownership letters that formally transfer ownership of 23 generic drug products to IDT Australia.

The FDA’s “Orange Book,” the register listing all US-approved drug products and their owners, will be updated in due course to reflect that.

IDT has successfully manufactured its first engineering batches of 1mg and 8mg doxazosin mesylate tablets at its manufacturing facility in Boronia, a suburb of Melbourne. The engineering batch manufacturing process involves matching the formulation and manufacturing process contained within the originator drug’s registration dossier. It is an important milestone for IDT to show the FDA that it can make the products according to the Administration’s approved registration.