Court Reverses Itself on NCE Issue-What Happens to ANDAs Already Received?

In a stunning reversal of opinion on the issue of FDA’s failure to award new chemical entity (NCE) exclusivity to the drug Prepopik, the world of NCE awards and ANDA acceptance for receipt for fixed dose combination (FDC) products that contain a first-time approved active ingredient may be turned on its head.  This was discussed in Kurt Karst’s excellent post on the FDA Law Blog (here) that details the legal issues of the case,

FDA Updates List of Guidance Documents It Plans to Issue in 2016

The FDA announced some additions (**) and revisions to titles (*) of Guidance documents it plans to release in 2016.  We have posted on this list previously (here) (and here) and highlighted this blogger’s impression of some of those proposed Guidance documents.  Well, FDA has published another revised list and here are the changes:

  • Comparative Analyses of the Device Constituent of a Drug-Device Combination Product Submitted in an ANDA ** –

ANDA Suitability Petitions Continue to Linger

As I dutifully read through this week’s Petitions and comments and Notices on, I came across a letter (here) telling FDA that the petitioner has responded to FDA requests and now the petition in over two years old and the petitioner wants FDA to expedite the review of its petition for an oral solution version of Trazadone.

Follow-up on New Final Rule for Drug Listing and Establishment Registration

After slogging through the 200+ pages of the Final Rule, here is a partial list of some of the comments I found interesting or that explain some of the changes or comments along with a summary of the FDA response from the Final Rule (here).

Comment 9 – Clarification of importers requirement to identify every entity it delivers product to will be narrowed in scope to the “importer”

19 Consumer Antiseptic Wash Ingredients Found Not to Be GRAS/GRAE

The FDA published a Federal Register (FR) notice today declaring that 19 ingredients for use in consumer antiseptic wash (use with water to wash off) are not generally recognized as safe and effective (GRAS/GRAE).  The Agency has however deferred a decision on three additional ingredients (benzalkonium chloride, benzethonium chloride, and chloroxylenol) for this use as additional studies and data are being reviewed at this time to support an Agency finding.

Opioids and Benzodiazepines to Get FDA’s Strongest Warning

The FDA announced in a safety warning today (here) that it was adding a Black Box Warning on all opioid and benzodiazepine products due to continued concern relative to potential fatal interactions and severe adverse events.  The warning notes that the “FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects,

202 Page FR Notice – Final Rule for Revised Drug Listing and Manufacturers Registration, Take Note!

Have some spare time on your hands?  Read the new Final Rule that FDA pre-published today (here) .  FDA says the rule, to become effective 90 days after final publication in the Federal Register (FR), is designed to modernize the drug and establishment listing requirements of sections 207 and 607, and to bring them in conformance with section 510 of the Federal Food,

“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).