Sure, in my opinion there is nothing wrong and this is all part of the ANDA review and approval cycle. So let me summarize how the GUDUFA dates work. Nasrat has already explained all of this but sometimes not in a clear and concise way.
A company files an ANDA for a product with the FDA through the FDA portal (online application process), FDA confirms receipt of the filing with 24hrs. The FDA now has 30-45 days to accept the filing for official review. This is when Elite puts out a PR to let everyone know the ANDA has been filed. With the acceptance for review letter, there is an associated GUDUFA target date assigned, from my experience this is running 9-12 months out. Now to be clear this is not a date the approval will happen and I think that is what is getting everyone confused. This date is the loose date that the FDA will communicate a Complete Response Letter to the filer. 95% of drugs filed get a CRL and do not go right to approval. Now the CRL can be classified as minor or major. Minor keeps your place in the review Que, while Major you start from the beginning again. Typically for a minor the FDA requires you to respond with answers and clarifications within 3 Months, a Major since it is usually a lot more they give you 12 months. You can respond any time within this timeframe. Once you respond to the CRL, the FDA usually takes up to 30 days to accept the response, if accepted they issue a new GUDUFA date, 3 months for minors and 9-12 months for majors. The process starts all over again. Usually after a minor CRL, approval is received after the review, however the FDA allows themselves the ability to issue Information Request Letters, this kicks the GUDUFA date out by another 1-2 months depending on the information being requested. Hope this helps clarify a little. Its a long process, but one Nasrat and team have navigated for many drugs and we just need to give them some slack as to be honest just getting one drug approved is hard for any company, my team has 20+ under our belts and each one is a new challenge and new FDA reviewer and comes with new requests. Based on what I have seen so far Nasrat and his team are doing a fantastic job, the new packaging facility was the key for me to realize we are headed to the next level and I have been heavily accumulating as well as my dad!! Good luck to everyone and no matter what happens moving forward it has been great sharing and reading everything on this board. Quite a little Elite family we have grown into!
AI
