Approvals

05
Oct

The State of Biosimilars and Generics 2023

The title of this blog was also the title of the presentation given by Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, Center for Drug Evaluation and Research.  I just could not think of a better title!  It is like the State of the Union address but not as expansive.  Dr. Corrigan-Curay spoke to the […]

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15
Sep
If You Are Looking for ANDA Approvals for September, Be Patient - Lachman Consultants

If You Are Looking for ANDA Approvals for September, Be Patient

This is a follow-up to the blog post “Houston, We Have a Problem” (here), noting that, with the exception of the one ANDA approval on September 5, 2023, no other ANDA approvals have been posted to either the Daily Approvals or All Approvals FDA websites through today! As I mentioned in that blog post, this problem […]

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08
Sep
August 2023 Delivers for ANDA Approval Actions Unofficially - Lachman Consultants

August 2023 Delivers for ANDA Approval Actions (Unofficially)

We had predicted, based on mid-month statistics (here), that August would be a big month for approval actions and, boy, was it! The OGD issued ninety-six full-approval actions along with twelve tentative-approval actions for a total of 108 approval actions. This was the second biggest month in FY 2023, behind the 117 approval actions in March […]

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29
Aug
Vyvanse_BlogImage_LachmanConsultants

Vyvanse Shortages Should Be Resolved but What Will the Market Do?

On August 25, 2023, the Office of Generic Drugs approved a total of 14 different applications for lisdexamfetamine dimesylate products after the expiration of a patent on August 24, 2023. (This is the first time in a long while where I remember this many applications being approved on a single day.) While this is good […]

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17
Aug

The Curious Case of the LateCycle Amendment under GDUFA III

Many of our blog readers have likely encountered moving goal dates for their ANDAs since October 1, 2022 and the beginning of GDUFA III.  The GDUFA III Commitment Letter, available here, included several new enhancements to the generic drug user fee program as each iteration of the program has continued to do.  The changes made to promote transparency […]

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02
Aug

June 2023 Official Generic Drug Statistics Including Mean and Median Approval Times Published

The statistical report (here) provides full official statistics through the third quarter Fiscal Year (FY) 2023.  There is some good news when looking at mean and median approval time that we will discuss later. But for now, let’s look at some of the more important FDA approval actions for June 2023. OGD approved 76 new […]

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