Elite Pharmaceuticals Inc (ELTP)

[Couch]

The CRL for Percocet is the first news about Elite to make me smile in a long time. Pessimists out there know exactly what I mean. I never bought into the claim that ANDA's would be reviewed in 10-12 months. I thought it was bull. The average was 36 months and some went much longer, so 12 months seemed optimistic. But FDA completed the full review cycle in less than 10 months! While any CRL is disappointing, a MINOR DEFICIENCY is easily fixed, and a MINOR AMENDMENT is quickly reviewed. Suddenly we have a finite time-frame for Percocet, and we also know the Norco ANDA is close behind. As of yesterday, we had no idea about these drugs. This filing is great news for our very near future and for every one of our drugs in development (several of the SunGen drugs should be close to submission). For the first time in a long time, we can move up the time-frame for great success, instead of moving it back.

Dr. Woodcock has been speaking publicly about the 10 month review cycle for all Andas. It is nice to see the FDA actually follow through on its expectations.

http://docs.house.gov/meetings/IF/IF14/20170302/105631/HHRG-115-IF14-Wstate-WoodcockJ-20170302.PDF

Faster review of priority ANDAs. GDUFA II would establish faster review of priority submissions. Priority review would be available for submissions that FDA considers to be public health priorities pursuant to CDER’s Manual of Policies and Procedures (MAPP) 5240.3 Rev.2, Prioritization of the Review of Original ANDAs, Amendments and Supplements, as revised (the CDER Prioritization MAPP). In the final year of GDUFA I, all ANDAs receive a review goal of 10 months. In GDUFA II, standard ANDAs would continue to be reviewed within 10 months of submission, but priority ANDAs would be reviewed within eight months of submission. To help ensure the more aggressive eight month timeline can be met, for each priority review, the applicant would have to submit a pre-submission facility correspondence (PFC) listing all of the facilities that will require FDA inspection at least two months prior to the date of ANDA submission.

You'll notice another novel approach to generic approvals. It sounds like the FDA has already begun to put this in place given Nasrat saying that the FDA did a pre approval inspection on 2 of Elite's Andas.

Pre-ANDA Program Enhancements. To reduce the number of cycles to approval, particularly for complex products, GDUFA II would establish a pre-ANDA program. It would clarify regulatory expectations for prospective applicants early in product development and help applicants develop more complete submissions, thus promoting a more efficient and effective review process.

I also like the sound of this new addition:

In GDUFA I, many deficiencies were communicated at the very end of the review, in the form of a Complete Response Letter, too late for the applicant to fix them. This produced additional cycles of review, and delayed approval. By contrast, GDUFA II would use “real time” communications to give applicants more opportunities to correct deficiencies in the current review cycle.

IMO the FDA will continue to streamline the ANDA approval process and I'd bet we see a 6 month timeline review in the next 2-3 years. At least one way to bring down the costs of generic drugs.