Adamis Provides Regulatory Update on Sublingual Tadalafil
Adamis Pharmaceuticals Corporation (ADMP)
Last adamis pharmaceuticals corporation earnings: 11/12 04:16 pm
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US:NASDAQ Investor Relations:
ir.adamispharmaceuticals.com/investor-overview
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Source: GlobeNewswire
SAN DIEGO, Feb. 26, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced that it has received a Refusal to File letter from the United States Food and Drug Administration (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 (i) longer real-time (versus accelerated) stability data and (ii) 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 concerni
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