Formalizing change of ownership is a process whereby the vendor and the purchaser both submit correspondence informing FDA that the transfer of a drug registration has occurred.

IDT bought the generics for US$13.5 million in an upfront payment and trailing payments of US$4.5 million payable upon attainment of regulatory and aggregate sales milestones back in November 2014. All of the products are or have previously been approved by FDA as abbreviated new drug applications (ANDAs).

IDT is now busy manufacturing exhibit batches of drug product that will be placed on stability studies. Engineering batches of high blood pressure treatment doxazosin mesylate tablets in 1 mg and 8 mg dosages have already been successfully prepared at IDT’s Boronia manufacturing plant. The data from the exhibit batch manufacture and stability work form the basis of a submission to FDA to reactivate the marketing approval of the products.

Dr Paul MacLeman, Managing Director and CEO, IDT Australia, said ‘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.’

The generics include 23 tablet and capsule products for conditions including Parkinson’s disease, depression, infections, hypertension and pain. The total current annual global market for these products in these presentations is approximately estimated at US$460 million, according to IMS data.

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