As the OGD has reported the official approval numbers for March, let us note that we projected the actual number (63) in our unofficial count (here) in our April 5th post. Please realize that this month (March) included a number of reports of approval actions for multiple strengths within a single ANDA, reflecting a change […]
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 […]
Yesterday, the FDA issued a long-awaited guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency (here). The guidance notes that the Agency will determine whether remote inspections will occur and which tools are appropriate as alternatives to on-site inspections but indicates that it will not accept […]
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 […]
The FDA notes that many of the emergency use authorization (EUA) tests currently being utilized are subject to false-negative results. The FDA emphasizes (here) that variants seen in the virus may have a significant impact on COVID-19 tests and this will likely occur with greater frequency, especially as some of the variants become predominant in […]
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 […]
