If you are one of the about 600 ANDA applicants submitted in the first 19 days of June, or have one of the additional ~ 100-200 ANDAs that have not yet received notification of acceptance for ANDAs submitted prior to June 2014, a decision is expected soon on what stability requirements you will need to meet upon resubmission. This issue was previously raised in a blog post here.
Everyone is holding their breath relative to the OGD’s yet-to-be-made decision. We hope to report on it to let you know as soon as we find out. Until then, keep your ears to the ground and hope for the best!
These are important questions, and it is nice to know that OGD recognizes the need to make decisions on these issues quickly so the industry can have some certainty. I have been at the Hatch-Waxman game for over 30 years now, and the one thing I learned early on, is that there is no way to answer all of the questions or consider all of the scenarios that may come up in advance. Just look at the likes of the Mova decision that threw 180-day exclusivity into a tizzy. Another example relates to the 5-year award of NCE, when considering combination products, when only one of the drugs in the combination has never been approved before. We know it can take only one court decision to change a past precedent or reexamination of a previous decision in light of a new view at FDA, or as presented by industry. So, in this fluid and dynamic environment of the generic drug review and approval process, change will raise new questions, and some answers will be challenged in court or past precedents will be revised. This is not an industry or time for the faint of heart!