With 11 reporting days into April, and 11 more to go, OGD has issued 25 full approval actions and 11 tentative approval actions for a total of 36 approval actions. One application for VILAZODONE HYDROCHLORIDE was responsible for two actions (1 full approval and 1 tentative approval), as only one of its strengths was eligible […]
OGD updated and provided the remainder of its monthly metrics for February 2021 in its Generic Drugs Program Activities Report – Monthly Performance (here). Here are some interesting observations! OGD issued 7 refuse-to-receive (RTR) actions which is the most since January 2020 when they also issued 7 RTR actions. All were for standard ANDA applications. […]
Okay, so you want to bring a product back from the dead. That is, you want to file an ANDA for an older discontinued product without competition and with no designated reference listed drug (RLD) or reference standard (RS) published in the Orange Book (OB). Oh yeah, and you also want to start a development […]
Yesterday, the FDA issued a guidance document titled Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers (here). The guidance covers three broad areas: Generic drug product development ANDA submission and assessment and Marketing and exclusivity. The guidance offers many hints on how the Agency may deal with issues that […]
We previously intimated (here) that March came in like a lion but might go out like a lamb; however, thanks to a flurry of approval actions in the last four days of the month, it looks like the lion might have stayed in the approval picture for most of the month. The unofficial number of […]
Well, a little late this month, but OGD posted the first wave of its February 2021 metrics. The Agency issued 72 Approval actions and 7 tentative approval actions (we reported 72 and 6 respectively (here -looks like they snuck in a late TA). So, a total of 79 total approval actions in February, which just […]
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 […]
Once an approved NDA product is discontinued from marketing or withdrawn, the FDA must make a determination that the reason for such action by the innovator was not for safety or efficacy reasons (see 21 CFR 314.161(a)). Such a determination must be made before an ANDA for a duplicate of the reference listed drug (RLD) […]
As we all know, the pandemic has wreaked havoc with inspections of drug manufacturers, API manufacturers, and laboratory facilities, as well as inspection of clinical study sites. Remote working, meeting problems, and just general pandemic fatigue has hindered some of the FDA’s work. However, the statistics are not as bad as one might think, all […]
