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.

Draft Biosimilar Naming Guidance Hits the Street

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.

Nine First Time Generic Approvals in July

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.

Office of Generic Drugs’ July Numbers Are In

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,