Confident business people are shaking hands after agreeing to a successful job. Business people shaking hands.Finishing up a meeting

Maybe There is a Reason After All!!

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 for lead;

Policy isolated on elegant green round button abstract illustration

Compounding Fairness???

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 of the Federal Food,

Interesting Feedback on Elemental Impurities

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,

FDA Warns of Potential Harm with Using Clarithromycin in Patients with Heart Disease

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.

Blackboard Business Strategy Concept

Only 5 Working Days Left in February, and Month Two of the Elemental Impurities Impact is Being Felt

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. 

Old Way x New Way Crossroad

A New OGD/OPQ Review Assessment Coming to an Application Near You – But Not for a While!

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.

Frontal view on a simple security barrier with a warning exclamation sign, isolated on pure white background. The image is suited for further compositing and derivation.

President’s Budget Has a Hidden Change to Hatch-Waxman — Watch Out.

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,

OGD Busy on the Bioequivalence Guidance Front

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.

lightbulb brainstorming creative idea abstract icon on business hand

Ah Ha!  Guidance from FDA on Elemental Impurities Issues

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,

Toy yellow forklift hold letter block F to complete word FAQ (Abbreviation of Frequently asked questions) on wood background

FAQ on Patents and Exclusivity – A Primer for Newbies and More

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).

Landscape from Antalya. A clean without humidity day

OGD Updates December 2017 Statistical Report

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.