Generics

In the first two years of GDUFA, the Office of Generic Drugs (OGD) DMF review team has been hard at work clearing up the backlog of DMF reviews and trying to figure out how to stay ahead of the game once the GDUFA metrics kick in in 2015. OGD did not want to penalize GDUFA submissions based on DMF submissions too severely because the DMF review process was so dramatically impacted and adjusted once GDUFA went into effect. So for years 1 and 2 of GDUFA, OGD exercised some regulatory flexibility in establishing a workable system. Now OGD has some advice for ANDA applicants that must be incorporated into your development and submission plans before your application is submitted.

The Office of Generic Drugs (OGD) is now receiving help from other CDER components in its battle to get the supplement backlog down. In May of 2013, OGD reported just fewer than 6000 supplements in its backlog. Today with a little help from their friends, the total supplemental backlog stands at less than 4000. What we don’t know is how many of the actions that took the supplements off of the OGD clock were Complete Response letters versus approvals.

Usually I concentrate on ANDAs received and the numbers approved as a measure of the Office of Generic Drugs’ (OGD) progress, but this month, let’s just mention that there were 41 full approvals and 7 tentative Approvals and, as the table below reveals, OGD received 74 ANDAs in April 2014. By the way, OGD reported issuing 100 Complete Response Letters in April 2014.

I have been getting lots of calls and questions on my blog post of May 15, 2014 on clarification of the stability guidance particularly on the issue of primary stability batch packaging. Apparently, the Office of Generic Drugs (OGD) has also received e-mails on this issue as well. So to clarify the clarification, here goes!

In a petition response issued on May 23, 2014to Hisamitsu Pharmaceutical Company, the FDA partially approved, but mostly denied the requests of the NDA holder for Salonpas (menthol and methyl salicylate 3%, 10%) Patch in a petition submitted on January 6, 2010. While the response did not come as much of a surprise relative to the NDA holders asks, the fact that the petition was submitted in 2010 and is just now being responded to is somewhat a matter of conjecture.

In a May 20, 2014 petition denial to Docket FDA 2013-P-1710 (the second denial on the same subject by the same firm), the FDA made clear that usability studies for transdermal systems are not a requirement for ANDA applicants.

In the Press Briefing Call this morning on the newly revised Q&A document on ANDA stability, three important and significant issues were clarified by the Office of Generic Drugs’ (OGD) Radhika Rajagopalan, Ph.D. that will have important implications for the generic industry.

With about one month to go before the Office of Generic Drugs (OGD) new stability requirements go into effect, a one hour briefing by invitation will be held on May 15, 2014 to discuss the new requirements. It will likely touch on the Draft Questions and Answers Guidance ANDA: Stability of Drug Substance and Drug Products, with (hopefully) an emphasis on any clarifications or revisions that have been made to the final guidance (to be published soon).