Over the last two days, the FDA has announced the recall of two products from two different companies (here and here), each due to the presence of particulate matter in the product. One was confirmed as glass particles and the other as a copper salt (particulates seen at the twelve-month stability station).
The FDA’s posting of the approval for the “priority” review ANDA for Valsartan mentioned yesterday (here) occurred today. The ANDA number was listed as 205536. It is interesting to note that the ANDA number corresponds to an application that was submitted around the middle of 2013. That is almost six years!
On March 12, 2019, the FDA approved an ANDA for Valsartan “to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of Valsartan and other ARB medicines contain nitrosamine impurities.” The Agency prioritized the ANDA’s approval but is it not yet clear how quickly the FDA approved the ANDA or when it was submitted as it is not yet listed on the approval site or in the Orange Book.
A federal judge entered a consent decree to a 503A compounder of sterile drug products in Texas. According to the FDA News Release (here), the compounding facility received repeated warnings from the FDA over a two‑year period but continued to compound sterile ophthalmic products. “The government alleges that Guardian manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act.
On Thursday, March 7, the FDA published a draft supplementary guidance on non-proprietary naming of biological products <here>, which updates the January 2017 Final Guidance on Nonproprietary Naming of Biological Products <here>. Both of these guidance documents address the FDA’s requirement for including a four-letter nonsense suffix in the proper name for biological products.
Each year, the OGD publishes a list of first-time generic approvals, which are defined by the agency as:
“First generics” are just what they sound like—the first approval by the FDA which permits a manufacturer to market a generic drug product in the United States. The FDA considers first generics to be important to public health and prioritizes review of these submissions.
Well, for the first time, our initial estimates of approval actions for a month was higher than the reported official figures, but are they really? Don’t know exactly how that happened because our estimates are usually below the totals. Anyway, the official figures posted today (here) were eight-two full approvals and seventeen tentative approvals.
In my own humble opinion, Scott Gottlieb’s resignation will come as a blow to both the industry and the public health of our nation. Dr. Gottlieb will stay in his position for about a month. There is no speculation as to whom his replacement will be, and, while some of the news outlets cite his taxing weekly commute to Bethesda/D.C.
So far, for February 2019, it looks like OGD fully approved 83 ANDAs and tentatively approved 23 ANDAs. Of course, the final official numbers won’t be in for about another week or so, but it looks like another month in the 100’s (OGD total of 100 or greater approval actions was missed only one month so far this FY).
The FDA has revised and finalized a guidance document, originally issued in draft on March 26, 2018, entitled Evaluation of Bulk Drug Substances Nominated for Use in Compounding under Section 503B of the Federal Food, Drug, and Cosmetic Act (here). After the posting of the draft guidance, the FDA says that it received approximately sixty comments from stakeholders and,
The Office of Generic Drugs issued its 2018 Annual Report, which contains the accomplishments of the generic drug program over the past calendar year. The report (here) provides data on approvals and tentative approvals, as well as other actions that OGD has taken over the year. Included in the report are links to various operational,
Today, the FDA issued a guidance titled Quality Considerations for Continuous Manufacturing (here). Talk about a controversial proposition! The generic industry has long held that implementation of continuous manufacturing might not be appropriate for their business. Why? I am not always clear on the answer to that question, but change is always difficult,
Today, the FDA issued twenty-two new bioequivalence recommendations, some of which were for some fairly old products, including a couple of DESI drugs. There were no surprises in the newly issued listings; however, as we have gone on about previously, the FDA has also issued fifty-two – yes, fifty-two – revisions to previously issued guidances.
Much like all we do at tax time, we look for anything that might lower our taxes. We look for deductions, charitable gifts, donations, business expenses and do a lot of hope and praying. Well, FDA had a corollary situation when they were looking at how to count and where to place ANDAs in the submission queue,
Today, the FDA issued a guidance document titled “Competitive Generic Therapies (CGT)” which describes the new statutory requirements under section 506H of the FDA Reauthorization Act of 2017 (FDARA). CGT was enacted to promote and incentivize the development, expedite the review (and thus approval) of certain previously approved drugs with little or no competition. In addition,