Generics

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 […]

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18
Jan

Official December 2022 ANDA Approvals, CRLs, and Receipts Hit the Web

We hit the number of December full‑approval actions on the head (thirty‑four) in our post here; however, we were way short on our estimate of tentative‑approval actions.  We noted thirteen at the time of publication in the above‑listed article but the official total reported this morning was twenty‑two.  Thus, the total number of approval actions […]

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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 […]

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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 […]

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17
Dec

December Mid-Month Generic Approval Actions Look a Bit Anemic

FDA approval actions listed through December 15th include only seventeen full‑approval actions and six tentative‑approval actions for a total of twenty‑three total approval actions.  As it stands, if these numbers represent one half of a month, it would mean that, at the current pace, we would see forty‑six total approval actions for the month of […]

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13
Dec

Another Additional Workload Issue That Will Actually Help FDA and Industry

On December 10, 2021, the FDA issued a guidance titled Cover Letter Attachments for Controlled Correspondences and ANDA Submissions, which can be found here.  The guidance suggests that ANDA applicants can help their own causes by utilizing a checklist as an attachment to the cover letters of ANDA submissions and controlled correspondences submitted to the […]

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