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Adamis Pharmaceuticals Announces FDA Acceptance for Review for the Supplemental New Drug Application
Feb. 13, 2018 10:07AM PST
Pharmaceutical Investing
Adamis Pharmaceuticals (NASDAQ:ADMP) announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review the Company’s supplemental New Drug Application (“sNDA”) for its low dose SymjepiTM product candidate for the emergency treatment of anaphylaxis. As quoted in the press release: The FDA further indicated that no potential review issues were identified and if no major …
Adamis Pharmaceuticals (NASDAQ:ADMP) announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review the Company’s supplemental New Drug Application (“sNDA”) for its low dose SymjepiTM product candidate for the emergency treatment of anaphylaxis.
As quoted in the press release:
The FDA further indicated that no potential review issues were identified and if no major deficiencies were identified in their continued review, they are targeting September 3, 2018 to communicate proposed labeling and, if necessary, any postmarketing requirement/commitment requests.
