Approvals

07
May
April 2025 Unofficial ANDA Approvals and Delay in Official Stat Postings - Lachman Blog

April 2025 Unofficial ANDA Approvals and Delay in Official Stat Postings

While we were able to piece together the April 2025 unofficial approval picture, we need to note that it has now been over three months since any official statistics from the Generic Drugs Program Monthly and Quarterly Activities Report have been published publicly (see here). This is a bit discouraging, but not totally unexpected, after […]

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21
Apr
A Peek at Mid-April 2025 Unofficial ANDA Approval Actions - Lachman Blog

A Peek at Mid-April 2025 Unofficial ANDA Approval Actions

With the first (albeit unofficial) count of ANDA approval actions since the layoffs at the OGD, the future does not appear bleak. At least not yet! The postings through April 16th for approval actions show that the OGD has issued 43 full-approval actions and five tentative-approval actions for a mid-month total of 48 approval actions, which […]

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16
Apr
Some More Interesting Tidbits from the Recent Generic Drug Forum - Lachman Blog

Some More Interesting Tidbits from the Recent Generic Drug Forum

The Generic Drug Forum was a two-day event held on April 8-9, 2025. This was one of the first public engagements that the Office of Generic Drugs (OGD) participated in since the current administration’s pause on FDA communications was announced in February 2025. There were many interesting sessions that presented an enormous amount of content. […]

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15
Apr
OGD Meeting GDUFA Goals for Original and Supplemental Applications - Lachman Blog

OGD Meeting GDUFA Goals for Original and Supplemental Applications

Presentations for the Generic Drug Forum, which was held in person and virtually on April 8-9, provided a look at the Office of Generic Drugs’ compliance with Fiscal Year (FY) 2024 User Fee goals for review of applications and supplemental applications. The OGD has met all of its review objectives from the GDUFA commitment letter for […]

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25
Mar
Final January 2025 Stats Released - Lachman Blog

Final January 2025 Stats Released – We Have Some Predictions for You!

As we approach the last week in March, we now have one-third of FY 2025 behind us. January’s ANDA approval numbers continue to look good, as we discussed in our February 6, 2025 post on the unofficial January approval actions (here). Another month with 90 total approval actions is good news for industry. The monthly total is […]

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19
Mar
Concern Around the Corner - Lachman Blog

Mid-March 2025 Peek at ANDA Approval Actions – Is There Concern Around the Corner?

The old saying “March comes in like a lion and goes out like a lamb” might apply to March 2025 as the OGD has issued 34 full-approval actions and 17 tentative-approval actions through March 17th. The biggest day was the first business day of March when the OGD pushed out eleven full- and four tentative-approval […]

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06
Mar
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February 2025 OGD Unofficial Approval Totals and Projections from First Quarter Results

The OGD unofficially issued 53 full approval actions and 16 tentative approval actions for a total of 69 approval actions.  For a month with only twenty-eight days and one federal holiday, the OGD’s approval-action total is not too bad.  Coupled with the great uncertainty regarding terminations and reduction in force of CDER employees, I think […]

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03
Mar
Official December 2024 OGD Stats Finally Out Along with New Mean and Median Approval Times - Lachman Blog

Official December 2024 OGD Stats Finally Out Along with New Mean and Median Approval Times

Almost two months to the day, the OGD published its final December statistical report along with the Quarterly Report on approval times for the first three months of FY 2025. It appears that the OGD did better in ANDA approval and tentative approval (TA) actions than we had reported back on January 6, 2025 in […]

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21
Feb
"Slow Down" Sign

Slow Reporting in February 2025 for ANDA Approval Actions Mid-Month

Even though it is February 21, 2025, we are only reporting ANDA approval actions posted through February 14, 2025, because approval actions have been slow to post on the daily approvals listing on the FDA web site, possibly impacted by the pause in the FDA communications imposed by the new administration. Thus far, through February […]

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