December 2019 Approvals and Receipts – Big Month for New ANDAs

With the end of the first quarter of FY 2020 approaching, the official numbers from FDA show a big jump from the meager number of new ANDA submissions the first two months of this FY with the December receipts hitting a 2 year high at 149.  Of course, this is likely due to getting the submission in to meet end of the year goals for industry,

OGD Approves 108 First Time Approvals in CY 2019

OGD reported the approval of 108 first time generic approvals in CY 2019.  This is the highest total in at least 4 years, with previous totals of 99 for 2018, 80 for 2017, and 73 for 2016.  There are many reasons for variations in the number of first approvals, some of which relate to the number of products that may be eligible for approval after a period of New Chemical Entity exclusivity,

FDA Publishes List of 249 ANDAs it Proposes to Withdraw

In the Federal Register pre-publication notices today, the FDA announced an opportunity for hearing for 249 ANDAs that it proposes to withdraw because the applicants have repeatedly failed to submit Annual Reports.  The notice announces the opportunity for a hearing for any of the applicants.  Many of the ANDAs are old applications, with some from companies that have been out of business for years;

OGD Updates November 2019 Metrics

Today is January 8th and the OGD just updated the November 2019 metrics (here) with the following information of interest: the OGD refused-to-receive three ANDAs (all of which were standard applications) and acknowledged fifty-five original ANDAs.

There were twenty ANDAs withdrawn in November (two were approved ANDAs that were likely no longer marketed) and eighteen were unapproved applications. 

Recall of Mirtazapine and FDA Warning Regarding Gabapentinoids Headline Agency Announcements Today

The Agency issued two warnings today, one about a recall due to a drug-strength labeling error for Mirtazapine and the other regarding a potential serious adverse event, breathing difficulties, associated with the use of gabapentinoids.

It appears that there was a label mix-up with a single lot of Mirtazapine and “Aurobindo Pharma USA,

Pre-Launch Activities Importation Request (PLAIR) Q&A Document Published by FDA

The Q&A document addresses a number of frequently asked questions about the Pre-Launch Activities Importation Request (PLAIR) process, and when you can or cannot use a PLAIR for importing unapproved drug product into the United States.  Quite interestingly, there are quite a few answers of “no” to the FAQs, which likely demonstrates that firms have been trying to apply the PLAIR process to situations for which it was not intended.

Our Holiday Gift (or Torture) to Our Readers

Each year at holiday time, we try to provide a little levity in some of our blog posts, as well as spread some good cheer.  So here you go – love it or not – we fully expect this to be sung outside Building 31 in Bethesda on the evening of December 24th.

To the tune of “Winter Wonderland,” this is “Winter Wonderland,

Proposed Rule for Drug Importation from Canada Hits the Federal Register

Today’s prepublication of the Federal Register contains the proposed rule for drug importation from Canada.  The proposed rule is 172 pages long and outlines the FDA expectations for the safe importation of drug products from Canada.  Section 804 Importation Programs (SIPs) provides the basis for each request for importation and provides the importation requirements.  The supply chain for each drug under a SIP would be limited to three entities,

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.

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.

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,