Guidance on TA’ed Applications Deserves TA – Total Attention!

In an unusual move, the FDA posted a guidance document on its webpage describing how to handle tentative approvals titled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs” (here) prior to its announcement in the Federal Register with this accompanying note:

“We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document.  

Official December 2018 Approval Numbers In – But What’s Missing?

OGD fully approved 69 original ANDAs and tentatively approved 31 for a total approval action of 100.  This is actually 18 more than we were able to spot on the FDA all approvals actions in our January 3rd post (here).  Not bad, considering the short month with vacations and the Federal government shutdown that started December 22 so actually represents a better result than what we anticipated.

OGD November 2018 Stats Updated

Despite the shutdown, it appears that the OGD is still pumping out ANDAs and updating required statistical metrics as it chugs along under what must be stressful conditions.

November 2018 (Month 2 of FY 2019) showed just four ANDAs received refuse-to-receive actions (four for standard ANDAs and one for a priority ANDA.  The OGD acknowledged ninety ANDAs and of the ninety‑nine approved ANDAs in November,

Approvals Actions for December 2018 won’t be a December to Remember

With the holidays, vacations and the partial government shutdown, OGD did not do too badly, with total approval actions of 82 and still a workday to go (and there are always those pesky approvals or tentative approvals that show up after the final bell).  This looks to be one of those “down months” that Cook talked about (I might add there have not been many of them recently),

Linaclotide Guidance Leaves BE Study with Clinical Endpoints as One Option but Also Provides for In Vitro Option as Well

Linaclotide capsules are “minimally absorbed with negligible systemic availability following oral administration.  Concentrations of linaclotide and its active metabolite in plasma are below the limit of quantitation after oral doses of 145 mcg or 290 mcg were administered.  Therefore, standard pharmacokinetic parameters such as area under the curve (AUC), maximum concentration (Cmax), and half-life (t½) cannot be calculated.”  Its site of action is locally in the bowel and intestines. 

Happy Holidays from Us to You!

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,

OGD Ties Its 128 Approval Actions Record in November Plus October Stat Update

It appears that 128 is the magic number for the OGD as last month they also had 128 approval actions.  November numbers saw a different split between full approvals and tentative approvals (99 and 29, respectively).  The 128 total approval actions obviously ties last month record number of approval actions for a single month.

Of interest,

FDA Withdraws Proposed Labeling Rule – Finally!

After just over five years, the FDA is officially withdrawing its controversial proposed labeling rule for generic drugs.  The advance publication notice in the Federal Register can be found (here).  The proposed rule would have permitted ANDA holders to unilaterally revise its labeling via a CBE-0 supplement to include new or different safety information or warnings. 

November- Another Good Month

Dr. Kathleen (Cook) Uhl said there would be good months and not-so-good months. Well, although the official numbers for November are not yet posted, it looks like OGD will have another good month.  Not a record breaker, but close, unless there are at least 4 more not yet reported approval actions lurking somewhere in the IT reporting system. 

OGD Issues Guidance on Post-Complete Response Letter Meetings

The Office of Generic Drugs has issued a guidance titled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA” (here) that addresses OGD expectations, procedures for obtaining such meetings, and timeline for scheduling and having the meetings.  As the FDA notes in the guidance: “FDA will only grant post-CRL meeting requests that pose questions to clarify identified deficiencies.  

22 New and 41 Revised BE Guidance Documents Posted!  AAM Continues to Voice Same Concerns

While we are thankful for the FDA’s work on issuing bioequivalence guidance documents, we worry about the impact of the constant and sometimes significant revisions to previously issued draft or final bioequivalence guidance recommendations on the review and approval process.  It seems that we are not alone!

In remarks made at the November 27th FDA meeting “Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions”,

Annual Report on Postmarketing Requirements and Commitments Shows Continued Progress

Congress has long been concerned that firms were not meeting their requirements for timely completion of postmarketing requirements and commitments (PMRS/PMCs) made at time of approval or post-approval in supplemental applications.  In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA) and, on September 27, 2007, the President signed the legislation into law.