Generics and the News – Bad Start to the Week or Just Business as Usual?

From the news stories on the price fixing suits, to the reported revelations about quality in the generic drug industry, or to the publication of a book titled “Bottle of Lies”, it has not been a good start to the news cycle for the generic drug industry this week.  The report on price fixing was met with a response to 60 Minutes May 12,

April 2019 Approval Actions, Receipts, and Complete Responses Posted

Today, FDA posted the official ANDA approval actions and receipts for April 2019.  While the All Approval list reported 93 full ANDA approval actions and 15 tentative approval actions for ANDAs, when we wrote our first blog estimating the approval actions for April on May 3rd  (here) ,   the official FDA numbers for April reported for approval actions was 98 and tentative approval actions was 18,

505(j) or 505(b)(2) – What’s Your Poison?

Today, FDA finalized a guidance document (initially issued in draft in October 2017)that discusses how to best determine if your proposed product should be submitted as an ANDA (505(j)) or an NDA (505(b)(2)).  We first blogged about this here.  The selection of the type of application to submit has been a source of discussion ever since the Hatch-Waxman Act of 1984 created the 505(b)(2) process,

Sleep Driving, Sleep Walking, and Other Misadventures Prompt Black Box Warning

FDA notes that it “identified 62 cases of complex sleep behaviors that resulted in serious injuries or death after taking insomnia medicines eszopiclone, zaleplon, or zolpidem reported in the FDA Adverse Event Reporting System (FAERS) database between December 16, 1992, and February 27, 2018, and four additional cases reported in the medical literature1-5 between December 16,

New Footnote Raises Questions About Approval Numbers

As I was reviewing the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here) as I do a few times a month, I came across a new footnote to the report.  It reads:

++++ = FY19 Approval and Tentative Approval counts were updated in April 2019 to better reflect program output by capturing all approval actions on original applications,

March Official Approval Numbers and Receipts Are in – We Were Close!

March 2019 actually saw 89 full approvals and 17 tentative approvals for 106 approval actions (our predictions were off by one).  This is another good month for ANDA approvals, but it is also a month that saw the largest number of ANDA submission for FY 2019 at 118.  We believe this corresponds to the end of the fiscal year for India,

March 26th a Big Day for Tadalafil – 15 ANDAs Stand Up to Be Counted

The 15 approvals for the generic of Cialis come on the day of the expirations of the 180-day exclusivity enjoyed by the first-to-file applicants.  Assuring that the ANDAs gain approval on the first legally possible date that they can be approved means that the price will go down and, when 15 ANDAs receive approval, the price decrease should be substantial.

Young woman with a flat tire

ANDA Suitability Petitions: The Way Back to Normalcy (and Some Sanity)

Coauthored by Kurt Karst (of FDA Law Blog) and Bob Pollock

The “Petitioned ANDA”—It’s a route to ANDA approval that’s been around since even before the enactment of the 1984 Hatch-Waxman Amendments.  For several years after the enactment of Hatch‑Waxman, the petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm.  

Approval Time Data Won’t Look Good Until the Oldies Are Cleared Out

Every day, when I look at the ANDA approvals list, I see that most of the approvals are for the older ANDAs that were submitted to OGD before Year 4 of GDUFA I (when goal dates started).  Some of these applications are anywhere from six to ten years old.  Once they receive approval, they have a “negative trend” on the mean and median time to approval reported by the FDA. 

Halfway Through March – OGD on Pace for Ninety Approval Actions

With numbers reported to date through March 15th,  it looks like the OGD will reach ninety approval actions this month.  There have been thirty-eight full approvals and seven tentative approvals reported so far this month.  With the OGD averaging eighty-eight full approvals for the first five months of FY 2019, it will need to push to get to that number by the end of the month,