Annual Report of 505(q) Petitions and Impact on the Delay of Associated Applications


The FDA is required to produce a yearly report that addresses the number of petitions filed during the previous year, the number of those petitions that were designated as 505(q) petitions, and the number of the 505(q) petitions that delayed whether a 505(b)(2) application, ANDA or biosimilar approval.

The FDA report (here) indicates that,

FDA to Publish ALL Comments Submitted by Individuals to Dockets on

Well, as someone who routinely reviews postings from the FDA, this comes as a bit of a surprise, because on some docket items there are literally thousands of comments to sift through.  Turns out that a pre-publication Federal Register notice (here) released today indicated that, back in 2007 when FDA merged its postings to,

FDA Is Diving Deeper in GMP Compliance for Compounding Pharmacies – A Follow-up

FDA Is Diving Deeper in GMP Compliance for Compounding Pharmacies – A Follow-up

Warning Letters and significant FDA 483 observations continue to confront the compounding pharmacy space. (See previous post here: With over 40% of compounders inspected receiving Warning Letters and nearly 100% receiving critical observations, can this industry respond effectively and meet FDA expectations?

Up the Ladder – Dispute Resolution Draft Guidance Gets 2nd Revision

Today, the FDA released its second revision to its “Guidance for Industry – Formal Dispute Resolution: Appeals Above the Division Level”. The revised draft Guidance expands the previous Guidance (released in March 2013) to include applications covered under the Biosimilars User Fee Act of 2012 (BsUFA) and provides additional clarification as to what matters are not appropriate for Formal Dispute Resolution Requests (FDRRs).

Second Potassium Chloride Oral Solution Approved by FDA – Will Enforcement Action follow?

On August 19, 2015, the FDA approved a second 505(b)(2) drug application for potassium chloride oral solution, a potassium replacement therapy typically for patients taking potassium-depleting diuretics. Previous to this approval, FDA approved another 505(b)(2) application for the drug on December 22, 2014.

Prior to that date, there were a number of marketed unapproved prescription drug products for potassium chloride oral solution on the market as “grandfathered” drugs or “DESI similar and related” drugs. The market for potassium replacement therapy is rather large and, while there are numerous approved solid oral dosage forms available in the marketplace, many patients cannot take those products for various reasons. Only time will tell, but one might think that this second potassium chloride oral solution approval may signal another enforcement action in the near future.

August 2015 ANDA Approvals Break a GDUFA Record, But Receipts Flounder

The Office of Generic Drugs (OGD) broke its old post-GDUFA approvals record of 57 by one, issuing 58 full approvals in August 2015. OGD issued 6 Tentative Approvals in the month for a total of 64 approval actions on ANDAs for the month. This is good news for OGD in a time of continued scrutiny by industry relative to its approval productivity. Quite interestingly, the number of new ANDA receipts for the month was only 32, the third lowest for this fiscal year, and gives OGD only its second month (and second month in a row) where approvals exceeded receipts this fiscal year.