Never on Sunday!?

The proverbial title of a 1962 hit song by Petula Clark is something that piqued my curiosity today.  And yes, I am that old (I was 13 when that song came out and I loved to play with my pet dinosaur).  Anyway, I digress!  The reason I bring up “Never on Sunday” is, because, as I flip through the FDA’s All Approvals list,

First Quarter FY 2018 ANDA Approvals, Receipts and More!

Well, the first quarter of approval actions for original ANDA and receipts are in the books.  We reported late last week that OGD fully approved 78 ANDAs and tentatively approved 19 ANDAs – well, we were as close as we ever have been, estimating using numbers derived from various FDA statistical reports… and the official numbers for November 2018 are – 78 full ANDA approvals and 20 ANDA tentative approvals for a total of 98 approval actions. 

DUE FEBRUARY 14, 2018 – One-Time Report on Marketing Status Required by FDARA- Don’t Forget!

To reiterate our post of December 27, 2017 (here), please start working on your one time report on the marketing status of your products listed in the Orange Book.  The deadline is approaching and FDA even republished its advice to industry (here) again today!

Don’t be left without a retort – be sure to submit your report!  

Draft Guidance and a MaPP to Help Firms and Reviewers Get It Right the First Time (or Second Time)

Today, the FDA issued a draft guidance entitled “Good ANDA Submission Practices” (here) along with a new Manual of Policy and Procedure (MaPPs) 5241.3, entitled “Good ANDA Assessment Practices: Manual of Policies and Procedures.” These establish good ANDA assessment practices for the Office of Generic Drugs and the Office of Pharmaceutical Quality to increase their operational efficiency and effectiveness.

New Year – New Class Labeling for Combined Hormonal Contraceptives

It has been quite a while since FDA totally updated the class labeling guidance for combined hormonal contraceptives (CHC).  FDA notes “this newer CHC labeling may be different from the labeling for some older CHC products. The updates to this guidance set forth labeling recommendations that represent newer class labeling that should be included in all CHC prescribing information consistent with the labeling requirements set forth in the PLR and PLLR (21 CFR 201.56 and 201.57)…”  There have been some minor modifications such as the “Content and Format of Labeling for Human Prescription Drug and Biological Products;

One-Time Report on Marketing Status Required by FDARA – Are You Ready?

After the glow of the holiday season, and after the big bowl games and national football championship, you better get the team prepared to file your one-time report of the marketing status of every one of your NDA and ANDA products.

FDARA requires every firm to submit the one time written report telling FDA if:

  1. the NDA or ANDA holder’s drug(s) in the active section of the Orange Book are available for sale;

First Time Generic Approvals 2013-2017


It is interesting that the FDA provides reports of first generic approvals by calendar year, but activity by fiscal year.  Today we will look at the last 5 calendar years of first approvals and try to make some assumptions of what these numbers reflect in the scheme of generic approvals in general.

Final Rule on Surgical Scrubs, Preps, and Hand Washes for OTC Use – Well, Almost!

FDA published a Final Rule (here), finding that 24 ingredients in the proposed monograph, “Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,” are not considered,  or generally recognized, as safe and effective (GRAS/GRAE) for OTC use.   However, as noted in the Rule, the FDA has deferred regulatory action on 6 active ingredients: benzalkonium chloride,

Don’t be a Glutton When It Comes to Gluten

In response to a petition denial, Docket No. FDA-2015-P-5081, asking the Agency to have products labeled with gluten content (here), the FDA has nonetheless issued a guidance document entitled “Gluten in Drug Products and Associated Labeling Recommendations”, wherein the Agency is permitting firms to add a statement to labeling regarding gluten,

STIC it to Me! FDA Says, “You Have One Year to Do It”

The labeling for approved antifungal and antimicrobial prescription drug products contains certain language regarding the susceptibility test interpretive criteria (STIC) and associated test methods and quality control standards, with associated references for antimicrobial drugs for the specific compound.  Many approved drug products have been around for a long time and the information regarding the STIC in their labels are outdated. 

RTR for NDAs and BLAs Submitted to CDER

Yesterday, the FDA published a draft guidance document titled Refuse to File: NDA and BLA Submissions to CDER (here).  It covers NDAs and BLAs submitted to the Center for Drug Evaluation and Research.  Unlike the long laundry list of issues that could result in a refuse-to-receive (RTR) determination for an 505(j) (ANDA) application,

Size Does Matter!

In a recent guidance issued by FDA entitled Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements (here), the Agency provides current guidance on the various aspects of proprietary and established names in advertising.

The document clarifies the relationship between the size (and not type size) of the proprietary name and established name in running text in advertisements and promotional material where the established name must be at least one-half the actual size of the proprietary name. 

AAM Letter to FTC – Issues Impacting Generic Access and Competition

The Association for Accessible Medicines (AAM) has penned a letter (here)  to the FTC, providing comments requested by that Agency relating to the Public Workshop held by FTC, Understanding Competition in U.S. Prescription Drug Markets: Entry and Supply Chain Dynamics, held  November 8, 2017 in Washington, D.C..

AAM (formerly the Generic Pharmaceutical Association [GPhA]) highlighted several areas of concern in their comments:

  • According to AAM,