25
Jan
Blackboard Business Strategy Concept

Peek at the January 2022 Approval Actions

With ANDA reporting through January 21, 2022, the OGD has issued thirty full‑approval actions and eight tentative‑approval actions for a total of thirty‑eight approval actions issued so far this month.  With only six more reporting days remaining, these unofficial numbers, gathered from the FDA All Approvals list here, it looks like the total approval actions […]

Read More
12
Jan

Saving the Skinny Label: Could Another Case Bring It Off the Respirator?

This morning, Sara W. Koblitz of Hyman, Phelps & McNamara posted a blog titled “Is The Skinny Label Back From the Dead?” (here) that suggests there may be hope for the skinny label after all.  The blog details the GSK v. Teva decision and the potential dire implications for the skinny label.  She also outlines […]

Read More
05
Jan

A Peek at December 2021 Approval Actions – Was There a Holiday Slowdown?

December of FY 2021 sure didn’t break any records as the OGD managed to eke out only 34 full‑approval actions and 13 tentative‑approval actions.  We would have to go all the way back to February 2018 to find a lower full‑approvals total for a month, and the total for that month was 32.  The tentative‑approval […]

Read More
23
Dec

IPledge Isotretinoin REMS Prompts FDA Flexibility and Plea to Manufacturers

The IPledge Risk Evaluation and Mitigation (REMS) program was designed to address the significant potential for serious birth defects should a pregnancy occur during treatment with the drug isotretinoin which is used to treat acne. The program covers both males and females, since isotretinoin can be passed through the semen of males if the male […]

Read More
21
Dec

CP Spurs FDA Decision that Alcohol in Dextrose was Withdrawn for Reason of Safety or Efficacy

In a move not often seen, a Citizen Petition was submitted asking the FDA to make a determination that certain Alcohol and Dextrose injection products were not withdrawn for safety or efficacy (S&E) reasons; In a Federal Register notice (here), the Agency took the opposing view and stated that all Alcohol and Dextrose injection products […]

Read More
06
Dec

New Dissolution Method for Long-Acting Injectable Suspensions May Provide Better Data

FDA and industry have long wrestled with appropriate dissolution methodology for injectable suspension products. Investigations into the relevance of the dissolution methods utilized has shown wide variation in in vivo results despite consistent in vitro performance. As FDA notes in a recent article (here) on the new potential improved method developed to address “gaps between […]

Read More
1 2 25