It will only be weeks until the User Fee carryover money for all the User Fee programs runs out. While Commissioner Gottlieb is doing his best to shuffle resources, the Agency will likely be up the perpetual tributary without any physical means of propulsion soon. Because the Agency cannot accept any new fee-paying applications since […]
In an unusual move, the FDA posted a guidance document on its webpage describing how to handle tentative approvals titled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs” (here) prior to its announcement in the Federal Register with this accompanying note: “We are posting this document on the FDA website […]
The Office of Generic Drugs (OGD) has taken great pride in meeting all of its GDUFA goals (including most, if not all, ANDA review goal dates). But, Houston, we may have a problem! Here are some facts that may have the OGD worrying into the future: December is typically one of the largest months for […]
OGD fully approved 69 original ANDAs and tentatively approved 31 for a total approval action of 100. This is actually 18 more than we were able to spot on the FDA all approvals actions in our January 3rd post (here). Not bad, considering the short month with vacations and the Federal government shutdown that started […]
Despite the shutdown, it appears that the OGD is still pumping out ANDAs and updating required statistical metrics as it chugs along under what must be stressful conditions. November 2018 (Month 2 of FY 2019) showed just four ANDAs received refuse-to-receive actions (four for standard ANDAs and one for a priority ANDA. The OGD acknowledged […]
I read four articles this morning that blamed high generic and brand name prices on everything from the confusion between list price and transactional pricing (here), to too much drug regulation (here), to PBMs and to the lack of negotiations between Medicaid and drug companies (here and here). I am sure that there are many […]
With the holidays, vacations and the partial government shutdown, OGD did not do too badly, with total approval actions of 82 and still a workday to go (and there are always those pesky approvals or tentative approvals that show up after the final bell). This looks to be one of those “down months” that Cook […]
Linaclotide capsules are “minimally absorbed with negligible systemic availability following oral administration. Concentrations of linaclotide and its active metabolite in plasma are below the limit of quantitation after oral doses of 145 mcg or 290 mcg were administered. Therefore, standard pharmacokinetic parameters such as area under the curve (AUC), maximum concentration (Cmax), and half-life (t½) […]
To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as […]
It appears that 128 is the magic number for the OGD as last month they also had 128 approval actions. November numbers saw a different split between full approvals and tentative approvals (99 and 29, respectively). The 128 total approval actions obviously ties last month record number of approval actions for a single month. Of […]
