Adamis Pharma files NDA at FDA for its fast-dissolving sublingual tadalafil tablet to treat erectile dysfunction.
Adamis Pharmaceuticals Corporation has announced the submission of a New Drug Application (NDA) to the FDA for its fast-dissolving sublingual tadalafil tablet. This product candidate is designed for the treatment of erectile dysfunction. Adamis submitted the NDA pursuant to Section 505(b)(2) of the Food, Drug & Cosmetic Act.
Adamis has been conducting pre-IND development work for a fast-dissolving sublingual tablet containing tadalafil with its first goal to demonstrate comparability to Cialis and additional benefits of a rapidly acting sublingual formulation.
Comment: If approved, APC-8000 will be a fast-disintegrating sublingual tablet containing tadalafil to treat erectile dysfunction.
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