This morning I read Joe Graeden’s (The People’s Pharmacy) article titled “Can You Trust Generic Drug Quality” (here) and, as a former longtime senior official at the FDA who worked in the Office of Generic Drugs and have consulted for the industry for over twenty-five years, I had a kind of knee-jerk reaction and wanted […]
The Lachman Blog has posted numerous writings on the issue of homeopathic drugs over the years that we have been publishing this blog. The most recent post on this topic was on June 17, 2020 (here). That post spoke about regulatory action taken against four manufacturers of homeopathic drugs in the form of Warning Letters. […]
The Agency has provided an updated list of drug products that are off-patent and have no unexpired period of market exclusivity and have no generic product approved. The revised list contains a 2-part listing and an appendix. Part 1 contains 269 targets products for “those drug products for which FDA could immediately accept an ANDA […]
OGD approval numbers have surged through June 15th as OGD has already issued 44 full approval actions and 4 tentative approval actions. 14 of those full approvals came on the 15th and 16th of June. Six of those approval actions were for Deferasirox Tablets, 90 mg, a generic of Jadenu. It appears that the block […]
The Office of Generic Drugs (OGD) updated its April stats and notes 4 refuse-to-receive (RTR) actions (3 standard ANDAs and 1 priority application) which is in line with what we have seen so far this entire FY (months average for 7 months is 3.6 RTRs/month). OGD also acknowledged 65 new ANDAs in April. Of the […]
Based on a news release titled, “FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic Drugs Pose Significant Risks to Patient Health and Violate Federal Law”, the Agency may be getting prepared to tackle regulation of the homeopathic drug market. In the release, the FDA announces that it issued Warning Letters to four […]
Hot on the heels of the FDA’s revocation of the emergency use authorization (EUA) of chloroquine phosphate and hydroxychloroquine sulfate for COVID 19, the FDA issued a new release (here) describing the newly discovered drug interaction with Remdesivir and the two drugs that just had their EUA revoked. According to the release, the Agency is […]
In an FDA new release (here), the Agency announced that it was pulling its EUA saying they “determined that the legal criteria for issuing an EUA are no longer met”. The Agency took this action after a review of the current state of knowledge on the two drugs relative to their unproven efficacy and serious […]
Today, the FDA posted MaPP 5220.2 (here), which outlines a little-known process (because it so seldom happens) that describes how the Agency will go about converting an ANDA approval to a tentative approval (TA). The issue only occurs when a patent challenge is won by the innovator after the expiration of the thirty-month stay and […]
When I started reading Kurt Karst’s blog post entitled “Code Orange – The Orange Book Archives Have Arrived” this morning (here), I thought, well, the FDA must have developed an archive of all of the old Orange Books (OB) and Kurt is announcing FDA’s good deed? Wrongo, beaver breath! It was Kurt and the folks […]
