The FDA has just updated previous warnings from July 1 and September 21, 2015 (here and here) for use of these two products in children. The new language contains stronger warnings in the form of contraindications for the use of the product in children under the age of 12 and in certain circumstances outlined below […]
When we look at the number of ANDAs coming into the Office of Generic Drugs (OGD), one might stop to say, how can this be? There has been so much M&A activity in the generic market, some would think that this might be a reason to see the number of submissions decrease or at least […]
In the “you learn something new every day” category, I got schooled by my good friend Lisa Parks from AAM this morning. After she read a quote from me pleading ignorance as to why there were so many ANDAs submitted in March, she cleared it up. It appears that March is the end of India’s […]
Today, FDA announced the current data they are collecting from which the “Program Fee” will ultimately be calculated for the three tiers of approved application holders. And while it is really not much of a surprise, based on some back of the envelope calculations we have done in the past, it may be a bit […]
According to our tracking of OGD approvals for March 2017 through the daily listings of approvals on Drugs@FDA: FDA Approved Drug Products (which was fairly close to the final numbers last month), there appears likely to be 59 full ANDA approvals and 16 tentative approvals reported when OGD issues final numbers in its Activities Report […]
FDA announced (here) that, so far this CALENDAR year through March 24th, the Office of Generic Drugs has approved 11 first-time generics. That appears to be a good start for the first three months of the year. All the first-time approvals can be viewed at the link above. Remember that not all first approvals will […]
Seems like almost every day a new Federal or State law is proposed to deal with drug pricing for both brand and generic pharmaceuticals. . The latest entries that appear to be making progress through the legislative process are from the states of Washington and Nevada. One can just imagine that there are specific differences […]
Paul F. Vogel has announced his retirement as Chairman of the Board of Lachman Consultants, effective March 31, 2017. Paul plans to spend more time with family and his many personal interests, following a 44-year career that included 21 years at the U.S. Food and Drug Administration followed by 23 years at Lachman Consultants. Richard […]
While there is not much new to report in the newly added numbers for certain metrics in the Activities Report of the Generic Drug Program for 2017 (here), there could be some raising of the eyebrows at the number of Complete Response Letters (CRL) issued in February (136), which is the lowest number issued for […]
Ever since I can remember, the submission date of an ANDA has been reported in the approval letter of the application. That practice stopped in early 2016, as reported in our blog post (here). The submission dates of applications are important metrics that help the industry to track approval times for applications. We heard a […]
