The FDA has released its most current list of Competitive Generic Therapy (CGT) ANDA approvals (here). CGT-designated products (products for which there is little, if any, generic approvals for NDA products) may be eligible to receive 180-days of market exclusivity from a subsequent ANDA approval for the same strength and product. After any ANDA approval […]
March came in like a lion and looks to be going out like a lamb. With seven reporting days left, we counted forty-nine approval actions and four tentative approval actions for the OGD. These numbers are tempered a bit by the fact that (as we have mentioned previously) the OGD reports every action it takes […]
For those of you that are not directly in the pharmaceutical industry or who are not healthcare providers, you may wonder why the FDA is having a meeting to discuss the morphine milligram equivalents for other opioids. Well, I know that measure gives healthcare providers a good idea of how to transition patients taking morphine […]
The unofficial approval-action numbers for ANDAs improved a bit from last month’s seventy, with the OGD hitting a total of full- and tentative-approval actions of seventy-eight. This breaks down to seventy‑two full-approval actions and six tentative-approval actions. These numbers are as of the morning of March 5, 2021 from the FDA’s All Approvals list (here). […]
The Office of Generic Drugs updated its Generic Drugs Program Activities Report – Monthly Performance for January (here) to fill in more data on various metrics. As you know, the Agency typically comes out with the number of ANDA approval and tentative-approval actions and receipts of original ANDAs, along with the number of complete response […]
On January 14, 2020, we posted a blog (here) concerning a Drug Safety Communication discussing FDA’s concern that the drug product Belviq or Belviq XR (lorcaserin) could increase the risk of cancer. On September 16, 2020, we posted a blog noting FDA’s final action withdrawing the 2 NDA drug applications for the product mentioned above […]
There appears to be some concern about Janet Woodcock, MD being selected for the permanent FDA Commissioner job. Not sure why there is so much hype and concern. Most of the pressure being applied from the non-supporters focus on the opioid crisis; however, some critics are being quick to complain about the approval actions that […]
OGD released its official numbers for approval actions, complete response letters and ANDA original receipts for January today, as well as updating metrics for December 2020. From our unofficial numbers reported for January, we hit the numbers of full approval actions on the nose at 62, but OGD snuck in an additional tentative approval action […]
Let me start off by saying you all know that I am a bit bitter about the lack of activity on the 505(j)(2)(C) ANDA suitability petitions. So, in an attempt to soothe my nerves and calm myself down, I looked back to January 1, 2020 to see how many ANDA suitability petitions have been filed […]
In the first 10 business days of February 2021, the Office of Generic Drugs has issued 30 full approval actions and 3 tentative approval actions for total approval actions thus far at 33. There are 9 business days left in this month and, of course, February is only 28 days in total. Even if the […]
