Adamis Pharmaceuticals Provides Update Regarding ZIMHI
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. 19, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) today provided an update on the ZIMHI™ New Drug Application (NDA) resubmission process. On November 22, 2019, Adamis received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its NDA for its ZIMHI high-dose naloxone injection product for the treatment of opioid overdose. On December 22, 2019, the company announced that it had provided responses to the comments raised in the CRL and had also requested a Type A meeting. The FDA scheduled the meeting for the second week of February. On February 12, 2020, Adamis met with the agency to discuss the CRL, Adamis’ responses and to determine the best path forward for ZIMHI. At the face to face meeting, the Company obtained concurrence from the agency on the Chemistry, Manufacturing and Controls (CMC) information required for resubmission of the NDA. The additional information involves extra
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