The Office of Generic Drugs (OGD) is evolving as the GDUFA process is gaining steam, and the pieces are coming together regarding coordination of reviews, and as efficiency in the review and approval process improves. Here are some interesting facts that have come out of OGD
With October 1, 2015 signaling the start of cohort year 4 of the GDUFA program, the receipt and approval numbers are in the book for first three years of the program. Let’s take a look at the numbers to see where we may be heading.
In a Federal Register (FR) Notice today (here) , FDA has indicated that a long-held practice of requiring the submission of actual or printers proof of final printed labeling (FPL) will no longer be required for ANDA approval, and that OGD will accept draft labeling for approval purposes.
The Office of Generic Drugs (OGD) approved 61 ANDAs in the month of September to close out fiscal year (FY) 2015 on a high note.
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 approved the first 3D printed drug product on August 3, 2015. The product, named Spritam (levetriacetam) is used to treat seizures. The product is listed in approved labeling as a “tablet for oral use.” Interesting terms for this new dosage form
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 The revised draft Guidance expands the previous Guidance (released in March 2013) to include applications covered under the Biosimilars User Fee Act of 2012 (BsUFA) and provides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,
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 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,