The FDA reviewed five (5) bulk drug substances for inclusion in the bulk APIs that can be used by outsourcing facilities in the compounding of drug products. The five (5) nominated for consideration were: quinacrine HCl, bromfenac sodium, mitomycin–C, nepafenac, and hydroxychloroquine sulfate. Only quinacrine HCL for compounding for oral products for the treatment of […]
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 […]
In a prepublication of a Federal Register notice (here) that will publish on March 3, 2021, the FDA has announced its intention to refuse to approve the 505(b)(1) NDA originally filed by Sanofi and now held by Lexicon Pharmaceuticals for Sotagliflozin Oral Tablets, 200 mg and 400 mg. The product was intended to be indicated […]
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 […]
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 […]
The generic community sprung into action with amicus briefs filed by the Association of Accessible Medicines and letters written by various other organizations to challenge the attack on the skinny label. Teva was able to convince the Court of Appeals for the Federal Circuit to rehear its skinny label case. Clearly, Congressional intent and regulatory […]
Today, The Hill hosted a webinar called “Complex Generics & the Prescription Drug Landscape.” Many thanks to The Hill for their efforts. The takeaway messages from the program participants are important, especially as the current Generic Drug User Fee Amendments III (GDUFA III) negotiations are revving up for the Office of Generic Drugs’ review and […]
We all can see from the OGD metrics that ANDA submissions and approvals have leveled off and have even gone down recently. In the negotiation meetings between FDA and industry for GDUFA III, it seems the Agency recognizes this, but there are some things that don’t seem to make sense and one item that is […]
As you know, we try to track the ANDA approval actions and report on other OGD metrics as closely and as early as we can to try to give you the most current and most timely information. The one thing we have found that the generic industry, as a whole, is most interested in are […]
