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 The revised draft Guidance expands the previous Guidance (released in March 2013) to include applications covered under the Biosimilars User Fee Act of 2012 (BsUFA) and provides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).
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.
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.
FDA released its long awaited Guidance on naming of Biosimilar products (Nonproprietary Naming of Biological Products – Guidance for Industry) today. In what is not too much of a surprise, especially after the first approved biosimilars name had a suffix (Zarxio, filigrastim-sndz), the FDA opted for most biosimilar products to have a suffix. In addition, FDA is proposing to assign a suffix to the originator biologic products.
As we reported here and here the FDA held a public hearing on April 20 and 21 to discuss a review of the regulatory enforcement policies relative to homeopathic drugs. The docket was open for public comment and we learned that the Federal Trade Commission (FTC) submitted its comments to the docket August 21, 2015. The FTC […]
or those of you who troll the CDER web page, you may have noticed that the Office of Generic Drugs (OGD) posted a revision of MaPP 5200.3 entitled “Communications with Industry with respect to pre-GDUFA Year Three Abbreviated New Drug Applications” last night. OGD’s issuance of revision 1 of the MaPP clearly provides industry with much of what they have been asking for.
Of the 47 ANDAs approved in July 2015, there were 9 first-time approved generic products. These represent the first time that the generic product was made available in the marketplace and demonstrates the Office of Generic Drug’s (OGD) commitment to getting first generics into the marketplace at the first available date.
The FDA has received numerous questions “about whether entities engaged in various types of activities (e.g., a facility that is compounding only non-sterile drugs or only repackaging biological products) should register as an outsourcing facility.” Firms are still confused about whether they qualify to register and this new document entitled, Guidance for Entities Considering Whether […]
The day after we reported on ANDA receipts, Approvals and Tentative Approvals, the Office of Generic Drugs (OGD) updated and revised its Activities Report of the Generic Drug Program for FY 2015. The update was through June but, again, not all data fields were updated.
The Office of Generic Drugs (OGD) fully approved 47 ANDAs and Tentatively Approved 12 ANDAs for a total of 59 approval actions. While the number of full approvals falls below last month’s GDUFA high of 57, nevertheless, it represents an above average month for approvals for OGD. The number of receipts in July was 40, […]
