On January 13, 2015, FDA denied an ANDA suitability petition requesting a change in dosage form from Ibuprofen Chewable Tablets, 100 mg to an Orally Disintegrating Tablet of the same strength. Anyway, FDA must have its reasons, and the Agency’s decision will stand unless the petitioner files a petition for reconsideration.
Well, it’s January 2015 and the Office of Pharmaceutical Quality (OPQ) is about to be stood up (“FDA speak” for official) and will be addressing quality issues across the New Drugs and Generic Drugs arenas. The concept is of one quality voice and one standard, but more about this in a bit. The new leaders of OPQ are outlined in a CDER posting relative to the new organization.
FDA issued a Guidance today entitled “Guidance Agenda: New and Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015”.
FDA issued a Guidance today entitled “Guidance Agenda: New and Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015”. This document gives us an idea of what is new and what changes we can expect on various issues over the coming year. It is not specific as far the specific changes that are upcoming, but at least it provides direction as to where changes or new advice may be forthcoming from FDA.
We know that there are a number of approved products that contain caffeine. But now, as noted in a recent article by the Associated Press found on Yahoo health (here), the FDA is gearing up for a legal battle to reduce the availability of caffeine powder being sold as a dietary supplement.
Well, after a lot of talk and years of discussion, “The Food and Drug Administration (FDA) is proposing to amend its labeling regulations at 21 CFR 201.100, 201.306, 201.310, 606.121, 606.122, 610.60, and 610.61 for human prescription drugs and biological products, and blood and blood components intended for transfusion, to require that the prescribing information (commonly referred to as the package insert) intended for health care professionals be distributed electronically and, with few exceptions, not in paper form.”
A December 10, 2014 petition filed by Wiley Rein LLP on behalf of Acura Pharmaceuticals (here) asks the FDA to require Purdue to file an ANDA rather than a 505(b)(2) application for a duplicate version of an immediate release oxycodone tablet with abuse-deterrent properties. The petitioner argues that,because the abuse-deterrent characteristics of the proposed Purdue product are similar to those of its Oxecta product, and because both products are pharmaceutical equivalents, that a firm should not be able to circumvent the listed patents on the Oxecta reference listed drug (RLD).
Just a few days ago, I posted a memo from Cook (Acting Director, Office of Generic Drugs [OGD]) about the new personnel changes there and the vision of how OGD will drive applications to approval. The plan sounds good and I believe we will see movement in the coming year (remaining 9.5 months of GDUFA year three). But today is December 15th and, thus far, we have seen only one approval in December.
Just weeks after the Office of Generic Drugs (OGD ) released a revised bioequivalence (BE) guidance for extended-release generic equivalents of Concerta and took action to revise the therapeutic equivalence code for the two generic approved products to BX (non-substitutable/not therapeutically equivalent), OGD released a new fairly onerous draft BE guidance for Budesonide Extended-Release Tablets.
On December 11, 2014, Dr Kathleen (Cook) Uhl, Acting Director, Office of Generic Drugs (OGD) sent the following memo to all OGD and CDER Ops staff announcing some personnel changes and revisions in the way OGD will be approaching the significant backlog of applications and how it will approach the GDUFA goals it must meet.
