OLON ANNOUNCES THAT ITS RIFAMPICIN DMF IS ELIGIBLE FOR GDUFA PRIOR ASSESSMENT AND IT MEETS THE REQUIREMENTS FOR NITROSAMINE STANDARDS
Within the framework of a consolidated and pioneering regulatory strategy, Olon announces that its Rifampicin Drug Master File is eligible for prior assessment, under the terms of the GDUFA III commitment letter.
The DMF prior assessment is a mechanism established by the Agency to enable assessment of DMFs in advance of certain ANDA and PAS submissions.
The new regulatory procedure is intended to facilitate and accelerate the market entry of generic drugs for which there are no more than three approved drug products listed in the Orange Book and for which there are no blocking patents or unexpired exclusivities listed for the RLD, through a more rapid and timely process that includes the option of early review of the API file submitted by the manufacturer indicating the partner with which the molecule is under development.
Thanks to the new policy, the FDA reviews the DMF before submission of the finished product application. This innovative approach has the great benefit of reducing significantly the issue time of regulatory approval and thus enables highly competitive timing of market entry.
The Olon group has applied its thorough knowledge of the international regulatory framework - in particular the US market, on which it has enjoyed numerous ‘first-to-file’ and ‘early-entering’ successes – to develop the new DMF of the API Rifampicin (treatment area Infectious Diseases, Bacteria) as eligible for an early review before the ANDA/PAS filing of the finished drug.
The development of the file was made possible, in particular, by strong investment in analytics to map the most demanding targets for the presence of nitrosamines, which ensured that we met the standards set by the FDA guidelines, which are crucial precisely to the regulatory review of Rifampicin.