“Proper” Was Not Proper in Guidance

Today, FDA reissued the Guidance for Industry: Abbreviated New Drug Application Submissions-Refuse to Receive for Lack of Justification of Impurity Limits, but the word “Proper” was removed from its title.  The title of the previous version read Abbreviated New Drug Application Submissions- -Refuse to Receive for Lack of Proper Justification of Impurity Limits (emphasis added).

Fidaxomicin BE Recommendations Consistent with FDA’s Vancomycin BE Recommendations-Almost!


Fidaxomicin, like vancomycin, is indicated for treatment of Clostridium difficile-associated diarrhea.  Both drugs are poorly absorbed systemically and treat the condition locally in the gut and intestines. Vancomycin, however, appears to be more soluble that fidaxomicin over the range of physiologically-relevant dissolution media.  The innovator of fidaxomicin submitted a petition,

So How Many ANDAs and 505(b)(2) NDAs Have Had Approval Delayed by Petitions in 2015?

For many years, innovators have used the petition process to gum up ANDA and 505(b)(2) approval process and hopefully delay FDA clearance of such applications.  Because of this problem, Congress was compelled to pass legislation (the Food and Drug Administration Administration Act [FDAAA] of 2007) to help correct this unintentional impact on generic drug, 505(b)(2) NDAs,

So How Many Patents Are Listed in the Orange Book Each Year?

Sponsors are required to submit information in their NDA filings to include “the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture,

July 2016 ANDA Approvals and Receipts Numbers Announced

The Office of Generic Drugs (OGD) released its July approval and ANDA receipt data today (here).  So far this FY, OGD has approved 548 original ANDAs or a monthly average of 54.8 (easy to calculate since this is month 10 of the FY).   OGD did say there would be good and bad months for approvals and the July number of 46 ANDA approvals is the second lowest this fiscal year (the lowest was 43 in January 2016).

Dietary Supplements Back in the News with FDA Issuance of New Draft Guidance

There has been a spate of blog posts on our site regarding dietary supplements and yet again today we are addressing a newly issued revised draft Guidance, entitled, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues (here).  FDA notes that, under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.

OTC Monograph User-Fee Comment Period Extended – Look at Comments So Far

In a pre-publication Federal Register Notice on Friday, August 5, 2016, FDA announced the reopening of the comment period on the issue of OTC Monograph User fees until October 6, 2016.  In addition, the Notice indicated that the FDA “will hold a Webinar for stakeholders on September 6, 2016.  This Webinar is intended to be a follow-up to the June 10,

Update of 2016 Activities Report of Generic Drug Program

Based on the updated numbers for 9 months of 2016 for metrics other than Approvals, Tentative Approvals, receipts of original ANDAs, which were reported on in a previous blog post (here), Office of Generic Drug (OGD) numbers point mostly towards higher numbers.

Some metrics have only been reported in the same context for the last two years (first years of GDUFA goals). 

Fiscal Year 2017 GDUFA Fees Announced

The GDUFA Fees for FY 2017 that go into effect October 1, 2016 were published today in the Federal Register (FR) (here). There are some interesting observations relative to the changes in the fees.  Original ANDA application and Prior Approval Supplement fees dropped by almost $6,000 and $3000, respectively.  While the number of ANDAs submitted in FY 2015 was the lowest ever during the first 5 years of GDUFA,