With summer in full swing and many people on vacation or thinking about their upcoming vacation, I decided to look forward to the fall and an upcoming GDUFA commitment on Suitability Petitions (SP) that begins on October 1, 2023. But first, let’s look back on events related to SPs in Calendar Year (CY) 2023. Earlier this year, […]
Back on January 30, 2023, I wrote a blog (here) concerning a petition that was filed by Vanda Pharmaceuticals regarding a perceived difference in labeling between the brand and generic drug. In this case (and please see original post to familiarize yourself with the details), the firm claimed that the generic excluded braille from its […]
A Citizen Petition submitted recently by McDermott Will & Emory (here) on behalf of Vanda Pharmaceuticals requests that the FDA “revoke approval of Abbreviated New Drug Application (ANDA) No. 211654, submitted by MSN Pharmaceuticals Inc. (MSN), for 20 mg tasimelteon capsules, and order a recall of any product that has been distributed under ANDA No. 211654 (if any) […]
Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]
Well, we have been seeing certain information on ANDA suitability petitions since FDARA passed, but only the information required by the Act. The FDA reports a separate list of petitions that have been filed, those that are pending, or those that have been acted upon. Unfortunately, according to the FDA page where the list resides […]
The ANDA suitability petition process has been languishing for years. Over the years, we have drafted many posts (here, here, here, here, here, here, here, and here, among others) regarding the FDA’s failing to act on what is a statutorily mandated ninety-day time period for approving or denying an ANDA suitability petition. Today, I read […]
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 […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
In a 21 page response (here) dated July 18, 2019 to Citizen Petition Docket No. 2019-P-0837 (here ), filed on February 20, 2019, the FDA determined that a carve out of an exclusivity-based and patent-based (potential little viii) statements regarding a supplemental application approval granting the inclusion of information on treatment of emergent sexual dysfunction […]
