09
Jun
Unofficial May 2025 ANDA Approval Actions - Lachman Blog

Unofficial May 2025 ANDA Approval Actions—Looks Like a Win!

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 […]

Read More
05
Jun
FDA Updates Generic Drugs Program Monthly and Quarterly Activities Report - Lachman Blog

FDA Updates Generic Drugs Program Monthly and Quarterly Activities Report—Big Time

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 […]

Read More
04
Jun
Minor Dosage Form Changes - Lachman Blog

Minor Dosage Form Changes to OTC Monograph Products Contemplated by Draft FDA Guidance

Today, the FDA published a draft guidance titled Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain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), […]

Read More
03
Jun
Do More with Less - Lachman Blog

Do More with Less – Looks Like That Is What the FDA Budget Request Asks

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, […]

Read More
02
Jun
Some Policy Staff Returning to CDER Now - Lachman Blog

Some Policy Staff Returning to CDER Now

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 […]

Read More
30
May
Color Additive Changes in a Drug Product – Regulatory Relief is on the Way - Lachman Blog

Color Additive Changes in a Drug Product – Regulatory Relief is on the Way

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 […]

Read More
20
May
Close up of man having itch caused of a red rash

Scratch My Itch

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. […]

Read More
16
May
Car engine with explosions and sparks.

Fits and Starts – ANDA Approval Actions Through Mid-May 2025

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 […]

Read More
1 2 41