March 2019 actually saw 89 full approvals and 17 tentative approvals for 106 approval actions (our predictions were off by one). This is another good month for ANDA approvals, but it is also a month that saw the largest number of ANDA submission for FY 2019 at 118. We believe this corresponds to the end […]
The OGD had what appears to be another good month, fully approving eighty-eight ANDAs and tentatively approving seventeen ANDAs for a total of 105 approval actions. While a few stragglers may still be lurking and not yet listed on the FDA All Approvals page (here), it looks like a good and productive month for the […]
The 15 approvals for the generic of Cialis come on the day of the expirations of the 180-day exclusivity enjoyed by the first-to-file applicants. Assuring that the ANDAs gain approval on the first legally possible date that they can be approved means that the price will go down and, when 15 ANDAs receive approval, the […]
Coauthored by Kurt Karst (of FDA Law Blog) and Bob Pollock The “Petitioned ANDA”—It’s a route to ANDA approval that’s been around since even before the enactment of the 1984 Hatch-Waxman Amendments. For several years after the enactment of Hatch‑Waxman, the petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm. And although […]
Every day, when I look at the ANDA approvals list, I see that most of the approvals are for the older ANDAs that were submitted to OGD before Year 4 of GDUFA I (when goal dates started). Some of these applications are anywhere from six to ten years old. Once they receive approval, they have […]
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). This is reminiscent […]
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! It is interesting to […]
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 […]
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 […]
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. However, […]
