Dear Dr. Fotouhi:
Please refer to your New Drug Application (NDA) dated and received December 20, 2016 submitted pursuant to section 505(B)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), for testosterone enanthate subcutaneous injection
As part of our ongoing review of your application, we have identified deficiencies that preclude the continuation of the discussion of labeling and postmarketing requirements/commitments at this time.
If you have any questions, contact Jeannie Roule, Regulatory Health Project Manager, at (301) 796-3993
As you can see, this is extremely vague. I don't have a 30 year career in pharma, but from those i've talked with, this is extremely odd. Not only were the deficiencies not stated, but it's odd that deficiencies wouldn't have been discovered until real late in the labeling stage of the review.
- Maybe this just precludes the FDA telling Antares on its PDUFA date that it will need more time to finish review?
- Maybe this just means that the FDA will issue labeling comments as part of a CRL on the PDUFA date of October 20th?
- Maybe this means that the FDA may require additional information in order to finalize labeling (like another clinical trial to back up a labeling claim)?
Given that the FDA is currently reviewing 3 TRT NDAs, in Lipocine's (LPCN) Tlando and Clarus' Jatenzo, maybe the FDA wants to try and consolidate labeling discussions.
Lipocine has already indicated that it will have an Adcom, although the date has not been set yet. With purported PDUFA dates of December (Clarus) and January (Lipocine), I'm guessing that the FDA will initiate Adcoms for both companies in back to back days, similar to how the PCSK9 inhibitors did.
Maybe the FDA has decided that in order to finish labeling or establishing post marketing commitments, it either wants to now include Antares in the Adcom or at least wait until they have outside experts weigh on? This would seem reasonable, however, why wouldn't the FDA have simply stated that they needed to extend the PDUFA date?
But instead they found deficiencies? This all just seems weird to me.
Disclosure: I am/we are long ATRS.