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,
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 ** –
As I dutifully read through this week’s Petitions and comments and Notices on regulations.gov, 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.
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”
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.
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,
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,
While there is not much new or trendy in the updated figures, it is clear that OGD is issuing more Complete Response Letters (CRLs). July saw the second highest number of CRLs for FY 2016 with 169 (highest was 190 in April). These numbers are also significantly higher than those in previous years.
This means one of two things,
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, 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,
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,
Our blog post of August 15, 2016 contained an error. What we meant to convey was that unless the capsule composition did not change, a PAS was required. We have changed the post to correct this error, and apologize any confusion that this might have caused.
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,
I can’t tell you how many times over my 33-year career that firms have asked me how to submit (or what category of supplement, i.e., Changes being Effected (CBE), CBE-30 or Prior Approval Supplements [PAS]) a capsule supplier change would be. I also have heard from many different firms about what changes were allowed by FDA in an Annual Report,
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).