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 […]
Many years ago, I wrote an article on the influx of Pharmacy Benefits Managers (PBMs) on the cost of prescription drugs (this was before much was really known about how they operated). In that article, I opined that I thought that they would be a great benefit to organizations that were not big enough to […]
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 seven of twenty-two business days left in the month, the OGD stands at twenty-seven full‑approval actions and seven tentative‑approval actions. The FY 2020 average for each category so far is just under fifty‑eight full‑approval actions and twelve tentative‑approval actions. Unless the end of the month picks up, we could see the slowest month for […]
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 […]
While I do happen to reside in California, I won’t take any blame for the Governor’s idea for California to become a private-label distributor of generic drugs. This idea leaves me scratching my head and may have something to do with someone smoking some really potent wacky weed. Sorry that I don’t know the specific […]
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 […]
I am saddened to report that on Saturday January 4, 2020 my (our) good friend Don Hare passed away peacefully after a brief illness. When I heard the news, my heart broke. For those of us in the FDA or in the drug industry, he stood as a man among men and will be sorely […]
