Getting back to the elemental impurities (EI) issue, we received additional interesting feedback from one ANDA sponsor. They said sometimes “this stuff gets tricky.” The sponsor related a situation of a capsule ANDA product that could be administered multiple times a day at high maximum daily dose. The empty capsule shell had the standard limit […]
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: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A […]
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 […]
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 […]
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. I […]
Lachman Consultant Services’ Ricki Chase sees too many companies falling down on design control activities when they set out to make combination device/drug products. Check out what she said here.
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 […]
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 […]
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, […]
