Well, another good month for approval actions at the OGD as it keeps the approval train in high gear. There were 69 ANDA full-approval actions in May. Please note that three of the full-approval actions were approvals of second strengths for previously approved ANDAs that were likely the result of delayed approval due to patent […]
Well I don’t know whether it was my continued questioning of the whereabouts of the last three months’ report figures, although I highly doubt it, or the rehiring of some of those policy people previously RIFed that finally gave the OGD enough bandwidth to get to the many things on its plate, with this report […]
Today, the FDA published a draft guidance titled Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs (here). This document discusses the conditions under which minor changes in dosage form (i.e., tablet or capsule to chewable tablets, orally disintegrating tablets (ODT), […]
Now, here is a head scratcher. According to the Pink Sheet article written by Sue Sutter (here), “The White House requested $6.76bn, a decrease of 3.9%, or $271.5m, from the FY 2025 funding level. The proposal includes $3.17bn in budget authority, a decrease of 11.4%, and $3.59bn in user fees, a 4% increase.” What a dandy, […]
Ever since the first patent settlements after the Drug Price Competition and Patent Terms Restoration Act was signed, many of us in the generic world (and now in the biosimilar world) have suggested that most patent settlements are pro-consumer as they can bring generic products (and now biosimilars as well) to market years before the […]
According to an article in the Pink Sheet (here, subscription required) authored by Sarah Karlin-Smith, some policy staff are returning to work at the Center for Drug Evaluation and Research. Hopefully that means that we will see more timely work on product-specific guidances (PSGs), informational postings, and statistical reporting from the Agency. In the Office […]
Yesterday, the FDA issued a draft guidance titled “Replacing Color Additives in Approved or Marketed Drug Products” (here). We all know that removing or partially removing a color from a product was an easy annual reportable change, and this remains unchanged in the draft guidance. However, changing a color by replacing it with another color […]
We mentioned the delay in publication of OGD statistics a couple of days ago in our post here. There has also been a delay, caused by the reduction in force at the OGD, of the publication of quarterly product-specific guidance documents (PSGs), but now the wait is over! According to the FDA announcement here, “[t]oday’s […]
The FDA warns about the potential for rare but severe itching after discontinuation of cetirizine or levocetirizine for both over-the-counter (OTC) and prescription drug products (here). The FDA says, ”[t]he itching, also called pruritus, has been reported in patients who used these medicines daily, typically for at least a few months and often for years. […]
In what has been a rather strange pattern of ANDA approval actions in May, the OGD has issued 36 full-approval actions and 5 tentative-approval actions in the first fifteen days of the month, which is a good result. However, the daily approval pattern seems a bit strange. On May 2nd, the OGD issued 9 full-approval […]
