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# FDA Refusal to File Letter on Adamis ED Drug
- URL: https://www.fdaweb.com/fda-refusal-to-file-letter-on-adamis-ed-drug/
- Published: 2019-02-27T12:00:00.000Z
- Updated: 2026-09-15T01:08:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143490

FDA has issued Adamis Pharmaceuticals a Refusal to File letter on an NDA for its sublingual tadalafil product, indicated for treating erectile dysfunction. Upon a preliminary review, FDA determined that the NDA was not sufficiently complete to permit a substantive review, according to the company. The agency requested that Adamis supplement and include in a resubmitted NDA (**1**) longer real-time (versus accelerated) stability data and (**2**) additional dissolution data for both the clinical and registration batches, the company says. Tadalafil is the active ingredient in Eli Lilly’s Cialis.