Statistics

06
Feb
What a Difference a Day Makes January 2025 Unofficial Numbers - Lachman Blog

What a Difference a Day Makes (at Least for Approval Information)! Well, Here Are January 2025 Unofficial Numbers

Powered up my laptop this morning and guess what I found? ANDA, NDA, and BLA approval actions had been updated from their last postings on January 22, 2025 after the pause on communications from the FDA. The best news is that January 2025 ANDA approval actions look great. As of today, the OGD has posed 64 […]

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09
Jan
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November 2024 Official OGD Statistics Published

The OGD published the second month of the Fiscal Year (FY) 2025 statistical report titled, Generic Drugs Program Monthly and Quarterly Activities Report (here).  There is some continued good news and also some troubling news in the report. On the positive side, we previously reported (here) in our unofficial posting, the full approval actions as […]

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06
Jan
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December 2024 Brought Gifts for ANDA Approval Actions (Unofficially)

The OGD had some late-month stocking stuffers as it issued 68 full-approval actions and 16 tentative-approval actions for a total of 84 approval actions in December.  Despite the hectic holiday schedule, if these numbers are confirmed in the official totals for the month, it would mean that the OGD managed to tie the second highest […]

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30
Dec
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FDA Updates List of Off-Patent, Off-Exclusivity Drug Products With No Approved ANDAs

Twice a year, the FDA publishes an update of the List of Off‑Patent, Off‑Exclusivity Drugs without an Approved Generic (see the December 2024 listing here).  This list is designed to generate interest from the industry in increasing competition among such products and it is made up of two parts.  Part I is for drugs for which […]

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17
Dec
December 2024 Unofficial Mid-Month ANDA Approval Actions - Lachman Blog

December 2024 Unofficial Mid-Month ANDA Approval Actions

As of December 15, 2024, just seven business days before Christmas, the OGD has issued 23 full-approval actions and 11 tentative-approval actions. With the holiday quickly approaching and facing what is likely a full FDA vacation schedule, what will the end of the month look like? A total of 34 full and tentative approval actions at […]

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09
Dec
OGD Official Statistics for First Month of FY 2025 Reported - Lachman Blog

OGD Official Statistics for First Month of FY 2025 Reported – ANDA Submissions Off to Slow Start

According to the first FY 2025 Generic Drugs Program Monthly and Quarterly Activities Report (here), the OGD had a good month for approval actions, issuing 62 full-approval actions and 20 tentative-approval actions for a total of 82. Only one month in FY 2024 had a higher combined total for these two metrics. That’s the good news! The […]

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