Generics

13
Apr

FDA Has Hinted at It, You Have All Been Waiting, and Now It Is Here – pH adjusters May Be Put to Bed!

Yes, you heard me right; after years of problems caused by those pesky pH adjusters, there is a way around the regulations (and by the way this avenue has always been available for the Agency to utilize).  In a pre-publication of the Federal Resister (here), the FDA says “an ANDA applicant for a drug product […]

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29
Mar
First

Update on First Generic Approvals in Calendar Year 2022

After almost three months of calendar year 2022, the OGD is reporting twenty‑two first-time generic approvals.  That seem like a whole lot but remember that if there are multiple first‑to‑file or first‑to‑approve ANDAs (which can sometime happen) for the same drug product, all of those that receive final approval on the same day are counted […]

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25
Mar
Female Chief Analyst Holds Meeting Presentation for a Team of Economists. She Shows Digital Interactive Whiteboard with Growth Analysis, Charts, Statistics and Data. People Work in Creative Office.

OGD Posts Official February Approval, CRL, and Receipt Numbers and Updates January Stats

We were close with our estimates for February approval actions, but the FDA reported one fewer full-approval action than we did (fifty-nine vs. sixty) and, upon review, note that it was because one of the ANDAs was listed in a separate line item as an action.  Sorry we missed that!  Of the fifty-nine full-approval actions, […]

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22
Mar

Deficiencies Abound – FDA Reports on ER and DR Application Study – Why?

The FDA released a summary table from a study report that was designed to help applicants for extended-release (ER) and delayed-release (DR) products; the FDA is aware of the types of deficiencies that are being seen and is making an effort increase the first-cycle approval rate for these products. The report summary (here) covers 186 […]

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21
Mar
The FDA Inactive Ingredient Database (IID) - Lachman Consultants

The Agency Requests Comments on IID – Will Changes Help or Hinder Drug Development?

In the prepublication of the Federal Register today, the FDA asked for comments on issues related to trying to reduce the confusion on maximum daily intake (MDI) and maximum daily exposure (MDE) limits in its Inactive Ingredient Database (IID).  The industry uses the IID to identify the level of inactive ingredients that may be safely […]

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16
Feb

Final Day at AAM Annual Meeting – “CEOs Unplugged” Highlights

The most popular program of each year’s AAM Annual Meeting is always the CEO unplugged session.  Oftentimes there are significant disagreements between the different CEOs regarding strategy, but this year there was almost complete agreement on strategic issues, policy, the marketplace, and regulatory issues.  The four panelists were Sven Dethlefs, Ph.D, Executive Vice President, North […]

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15
Feb
Key Points

Some Highlight Facts from the AAM Annual Meeting on Tuesday – Oh, and, By the Way, Robert Califf was Confirmed as FDA Commissioner Today!

(Not that we had anything to do with Califf’s confirmation but we are all glad that this is in the Agency’s rearview mirror and it now has a permanent rudder for the foreseeable future.) Anyway, the AAM annual meeting is in full swing and I thought that I would give a few bullet points of […]

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