We do not often blog on the issue of dietary supplements but in this case the FDA is making a serious point by issuing a guidance entitled “Highly Concentrated Caffeine in Dietary Supplements” which can be found here. This comes after several deaths from consumers taking lethal doses of pure or highly concentrated powers or […]
The FDA has struggled with the best methods to determine the bioequivalence of topical dermatological drug products for years. For example, FDA considered numerous methods including transepidermal water loss (TEWL), skin stripping, and others to demonstrate the bioequivalence of retinoid acne products. None were found acceptable and the Agency ultimately relied on bioequivalence studies with […]
On April 12, 2018 FDA posted yet another recall announcement by a registered outsourcing facility (here). Ever since the New England Compounding Center’s problems associated with the meningitis outbreak, FDA has been diligently inspecting compounders registered as outsourcing facilities with the Agency. Today’s announcement highlights a continued sterility assurance concern by the FDA. This latest […]
Here we are at April 11th and through the 9th, the first 6 business days of April, there have been 5 ANDA full approvals reported so far on the FDA’s Recent and New and Generic Approvals list (here as of the morning of April 11th at 730AM). April 2 and 3 saw no approvals reported […]
OGD just released its March 2018 ANDA Approvals and receipts data. The results are even stronger than reported earlier (here). March officially saw 56 full approvals and 11 tentative approvals, a few more than we saw on April 3rd, as the databases became fully populated over the next few days. None of the approvals or […]
Before we get to the guessing game, for those of you who are not familiar with the term, let’s define what an Authorized Generic (AG) is. Most commonly, an AG is a brand name drug that is marketed without the brand name. It may be marketed directly by the NDA holder or by a third […]
March approvals appear to be moving in the right direction as firms, apparently, are catching up with elemental impurity issues and their amendments are working their way through the review and approval process. Unofficial March ANDA approval numbers taken from the Recent New and Generic Drug Approvals list (here) show 50 full approvals and 10 […]
It has been just about 11.5 years since FDA approved an OTC version of MiraLAX and the innovator withdrew the Rx-labeled NDA product from the market. Why did it take this long? Other than the fact that ANDAs approved prior to the approval of the OTC version were making significant profits, there were differences between […]
Everyone associated with generic drug submission realizes that generic companies that want to market a copy of a drug product prior to the expiration of a patent must file a patent challenge to existing patents (a so-called Paragraph IV [“PIV”] challenge). FDA updates its list of PIV submissions so other firms will know the date […]
Under Section 902 of the Food and Drug Administration Reauthorization Act (FDARA) of 2017, the FDA is required to annually publicly report information regarding certain statistics on inspections of facilities associated with the approval of drugs and devices and the impact that they might have had on delaying applications. The calendar year 2017 report has […]
