The FDA has confirmed receipt of the change of ownership letters formally transferring ownership of the 23 generic drug products to IDT Australia Limited, according to a company press release.
The company also announced the successful manufacture of engineering 1mg and 8mg Doxazosin Mesylate tablets in IDT's Boronia manufacturing facility. Engineering batch manufacture involves matching the formulation and manufaceturing process contained within the original drug registration dossier.
"The successful manufacture of Doxazosin in IDT's Boronia solid oral dosage form facility is a turning point for the company in that we have now shown that IDT has the personnel, equipment and resources required to manufacture these newly acquired products in-house," said Dr. Paul MacLeman, Managing Director and CEO of IDT Australia.
Following the success of the engineering batches, IDT will now move on to the manufacture of exhibit batches of drug product that will be placed on stability studies. The data from the exhibit batch manufacture and stability work form the basis of a submission to the FDA to re-activate the marketing approval of the products.
The names of those drugs were not immediately available.
