Amneal Throws Their Hat into the Ring

Without much fanfare, on November 11,, 2019, OGD approved the first generic vaginal contraceptive ring.  Amneal’s approval showed up today on the Drug@FDA, FDA approved drugs list.  It is a therapeutic equivalent to Nuvaring by Organon/Merck.  Given the ANDA number, it appears that the application was submitted about early to mid-2018, which by all standards for a complex generic product is somewhat amazing to say the least.

November 2019 Approvals and Receipts Official Numbers

Based on our post previewing the November totals, there were some late added approvals that did not initially show up on the Agency approval databases.  We reported 49 full approval actions and 8 tentative approval actions on December 3rd.  With the release of the official November numbers (here), OGD issued 59 full approval actions and 10 tentative approval actions,for a total of 69 approval actions for the month or 4 more than last month (57 full and 8 tentative approval actions).

Hand with classic stopwatch

Will Blocking Act Block Savings?

In a blog post, Kurt Karst (Hyman, Phelps, and McNamara) addressed at least one very significant issue the proposed Blocking Act of 2019 could have (here).  Many believe that the change from the current legislative language may erode the value of 180-day exclusivity and, in the long run, could lead to higher drug prices.

Back view business woman raising hand for asking speaker for question and answer concept in meeting room for seminar

Woodcock and Churchward Give Stimulating Presentations at Last Week’s ISPE Global Regulatory Summit

The International Society of Pharmaceutical Engineering (ISPE) held their premier Global Pharmaceutical Regulatory Summit conference this past Thursday and Friday (December 5 – 6, 2019) in Bethesda, MD.  The theme of this year’s conference was “Igniting Innovation in Development & Quality During Lifecycle Management”.  The conference opened with excellent keynote presentation from Janet Woodcock (Director of FDA’s Center for Drug Evaluation and Research) and David Churchward (Deputy Unit Manager,

The Case of NDMA – Is Metformin Next?

N-Nitrosodimethylamine (NDMA), which was previously found in angiotensin II receptor blockers (the ‘sartans”), which are blood pressure medications, and more recently, in ranitidine  (a heartburn medication) has caused nationwide recalls of the products.  Now there is a hint that metformin, a widely used drug for diabetes, may be implicated as well, as Singapore’s Health Sciences Authority (HSA) recently announced a recall of several lots of the product in Singapore.

Baseball Player Hitting Ball During Baseball Game In Outdoor Stadium

Training Fundamentals: Important to Baseball and the Analytical Laboratory

Baseball season ended over a month ago, and I am already looking forward to when teams report for spring training.  At this time, team management is evaluating where the team succeeded and where improvement is needed.  It is interesting that the ICH Q10 Pharmaceutical Quality System guidance recommends pharmaceutical management take the same approach towards quality objectives. 

How Much Does the Clear Out of the Backlog Really Impact Approvals?

Reading Derrick Gingery’s article “ANDA Approval Records Will End As U.S. FDA Mops Up Backlog” (here) in today’s Pink Sheet about Dr. Woodcock’s contention that the clearance or “mop up” of the backlog will impact the number of generic drug approvals, I was somewhat stopped in my tracks.  Granted, the backlog of old applications did contribute to the number of approvals but,

Novel Excipients – FDA Evaluates a Novel Program

Excipients are components used and intentionally added to a drug product with no expectation that they will have a therapeutic effect.  A novel excipient is one that has never been used and “reviewed in an FDA approved drug product or does not have an established use in foods”.  Since the beginning of time, the Agency has struggled with evaluation of novel excipients in INDs,

Happy multi-generation family holding Thanksgiving turkey together at dining table.

Hope at This Time of Giving Thanks

Just look around, watch the television, read the newspaper, and what do you see?  Seems like very few reasons to be thankful.  School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth.  Climate change is threatening the future of our children, and the environmental controls have been set back 50 years as the oceans continue to rise,

New and Revised Product-Specific Bioequivalence Guidances Announced

In the prepublication page of the Federal Register Notice (here) published today, OGD announced 28 new bioequivalence recommendations and revised 53 previously issued recommendations.  While the new and revised guidance documents appear on the listing of Product-Specific Guidances for Generic Drug Development (here), the links to the new and revised documents were not yet active at the time of this writing.

October 2019 Approval Actions and Receipts Reported by OGD

OGD reported the official approval actions, receipts, and Complete Response Letters for the first month of FY 2020.  There were 57 full approval actions and 8 tentative approval actions for a total of 65 approval actions for the month of October (we reported 52 and 9 actions respectively here), so it appears that there were some adjustments made to arrive at the final official numbers (along with some delay in reporting full approval actions).

With Thanksgiving on the Horizon, November ANDA Approvals Status

With the FDA reporting posted through November 18th, the OGD has issued full-approval actions for just twenty-four ANDAs and has issued tentative approval actions for two ANDAs.  Thanksgiving week is a notoriously slow week for approval actions due to the holiday and staff absences, so November looks like it will be a somewhat lean month for approvals.