As the compounding Industry awaits the next round of Guidances from FDA on using bulk drug substances, one point of controversy appears to be the fairness of compounding for 503A and 503B entities. The most recent Guidances for Compounding from Bulk Drug Substances are:
After my post on Thursday (here) regarding the slowdown in ANDA approvals because of lack of documentation of elemental impurities, and my assumption relative to NDA applicants, I received some interesting feedback from two NDA applicants. I was told that the New Drug Division would not hold up issuing an approval action letter if the only issue was that of elemental impurities,
The new warnings which FDA says will be incorporated into both clarithromycin’s brand (Biaxin) and generics labeling come after review of a number of long-term studies revealed an increased risk of death in patients with preexisting coronary disease. The interesting finding is that the risk is not necessarily immediate, but can occur in patients with preexisting heart disease years after taking the drug.
As of this morning, there were only 20 full ANDA approvals and 2 tentative approvals listed on FDA All Approvals list (here). In contrast, there were 9 NDAs with full approvals and one tentative approval. Looks like ANDAs have been more impacted by the elemental impurities (EI) documentation requirement than it has for NDAs.
Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER) at the AAM Annual Meeting today, gave some hope to generic applicants regarding the way agency assessments will be conducted in the not too distant future. The goal is to improve the efficiency and effectiveness of the review process. Why is this necessary? Dr.
There is a proposed change to 180-day exclusivity which is awarded to the first -to-file (FTF) applicant with a paragraph IV certification. The proposal would trigger the 180-day exclusivity period if a subsequent applicant obtains tentative approval prior to the FTF applicant gaining final approval. While this on its face may in some instances appear to permit a generic applicant to enter the market faster,
In the newest posting of bioequivalence (BE) guidance documents (here), the Office of Generic Drugs has issued 35 new guidance documents and revised 22 previously issued guidances.
We have previously posted about the impact of revised BE guidances and now there are 22 more that firms must review to see if any of the changes recommended will mean more work or repeat studies.
FDA updated its Activities Report of the Generic Drugs Program Monthly Performance FY2018 with its January ANDA approvals and receipt numbers. The 25 full approvals reported for January is the lowest number since July 2014, when there were just 18 approvals. We have blogged about the potential for a very low January approval number here,
It looks like our guess was correct, and it also looks like OGD either liked our suggestion or, on its own initiative, decided to provide guidance to ANDA applicants concerning the best way to handle the submission of documentation on meeting the elemental impurities issue!
The one pager (here) discusses the fact that submission of the information as an unsolicited amendment as soon as possible,
The FDA published a Frequently Asked Question (FAQ) on Patents and Exclusivity on Friday (here). Turns out it is a very nice primer for those new to the generics or 505(b)(2) game or those that need a refresher in the ins-and-outs of two of the most contentious and confusing issues associated with the Drug Price Competition and Patent Term Restoration Act of 1984 (better known as the Hatch-Waxman Act).
I must honestly say that there is not a lot that stands out in this update for the December ”Activities Report of the Generic Drug Program Monthly Performance” that we have not either already commented on, or where there appears to be a significant trend, albeit there are a couple of issues that we point out for further scrutiny when more data for this FY is available.
We have long heard arguments that traditional and Outsourcing compounding entities represent unfair competition to the generic drug industry and that they frequently circumvent the Federal Food, Drug and Cosmetic Act (especially the 2013 Drug Quality and Security Act, DQSA).
A new tactic that has been recently used by a generic firm to protect its approved product was to sue FDA on the grounds that the FDA Interim Policy on compounding using bulk drug substances (APIs) under section 503B of DQSA is contrary to law.
Here we are on January 29th and so far this month, there have been only 12 ANDAs approved and one tentative approval which have been posted on FDA daily approvals list. This month, January 23rd tops the number of approvals with 3 approvals listed. In previous months, we have seen as many as 11 approved on a single day.
Just days after FDA Commissioner Dr. Scott Gottlieb shared the 2018 Compounding Policy Priorities Plan, FDA issued three guidances:
There is a big buzz about a new player in town but not a lot of information on how it plans to operate. Drug Store News reports “There will soon be a new generics manufacturer to contend with — one that comes with a built-in base of 450 hospitals. Four major health systems — Salt Lake City-based Intermountain Healthcare,