Adamis receives a Refusal to Sign Letter from FDA for sublingual tadalafil to treat erectile dysfunction.

Adamis Pharmaceuticals Corporation announced that it has received a Refusal to File letter from the FDA regarding its New Drug Application (NDA) for its sublingual tadalafil product. As previously announced, on December 28th, 2018, Adamis submitted an NDA for fast-disintegrating sublingual tadalafil (APC-8000) with the FDA for the treatment of erectile dysfunction (ED).Upon its preliminary review, the FDA determined that the submitted NDA was not sufficiently complete to permit a substantive review.

The FDA requested that Adamis supplement and include in a resubmitted NDA longer real-time (versus accelerated) stability data and additional dissolution data for both the clinical and registration batches. Adamis may seek immediate guidance from the FDA, including requesting a Type A meeting, to discuss the letter with the agency and seek additional guidance concerning information, data and specific deliverables that the agency would require for a resubmitted NDA to be deemed complete.