The FDA released its most current version, its “Guidance Agenda: New & Revised Draft Guidances: CDER Plans to Publish During Calendar Year 2020,” yesterday and there are some interesting things for generic and new drugs. The complete document can be viewed here, but we will highlight some of what we believe might be the most […]
If you are, or plan to be a sponsor of a Generic ANDA, do not let this slip by you. The FDA on January 30, 2020 revised its Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements to make changes to the prioritization scheme for the review […]
The FDA has provided a list of all products approved under the Competitive Generic Therapy (CGT) designation program under section 506H of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This exclusivity is awarded for products with limited generic competition and provides for a potential 180-day exclusivity marketing period. On its current list (here), […]
With the end of the first quarter of FY 2020 approaching, the official numbers from FDA show a big jump from the meager number of new ANDA submissions the first two months of this FY with the December receipts hitting a 2 year high at 149. Of course, this is likely due to getting the […]
OGD reported the approval of 108 first time generic approvals in CY 2019. This is the highest total in at least 4 years, with previous totals of 99 for 2018, 80 for 2017, and 73 for 2016. There are many reasons for variations in the number of first approvals, some of which relate to the […]
In the Federal Register pre-publication notices today, the FDA announced an opportunity for hearing for 249 ANDAs that it proposes to withdraw because the applicants have repeatedly failed to submit Annual Reports. The notice announces the opportunity for a hearing for any of the applicants. Many of the ANDAs are old applications, with some from […]
Today is January 8th and the OGD just updated the November 2019 metrics (here) with the following information of interest: the OGD refused-to-receive three ANDAs (all of which were standard applications) and acknowledged fifty-five original ANDAs. There were twenty ANDAs withdrawn in November (two were approved ANDAs that were likely no longer marketed) and eighteen […]
The Agency issued two warnings today, one about a recall due to a drug-strength labeling error for Mirtazapine and the other regarding a potential serious adverse event, breathing difficulties, associated with the use of gabapentinoids. It appears that there was a label mix-up with a single lot of Mirtazapine and “Aurobindo Pharma USA, Inc. is […]
With the first quarter of FY 2020 in the rearview mirror, a review of the FDA’s All Approvals list (here) and the FDA’s Recent New and Generic Approvals list (here) looks like the new monthly normal for full approval actions will likely be close to sixty per month with about an additional ten tentative approval […]
The Q&A document addresses a number of frequently asked questions about the Pre-Launch Activities Importation Request (PLAIR) process, and when you can or cannot use a PLAIR for importing unapproved drug product into the United States. Quite interestingly, there are quite a few answers of “no” to the FAQs, which likely demonstrates that firms have […]
