Data from Pharmawand - Curated by EPG Health - Date added 13 February 2018

Adamis Pharmaceuticals Corporation announced that the FDA has accepted for review the Company’s supplemental New Drug Application (“sNDA”) for its low dose Symjepi product candidate for the emergency treatment of anaphylaxis. On February 9, 2018, Adamis received FDA correspondence relating to the company’s sNDA stating that the Agency had completed their filing review and had determined that the sNDA was sufficiently complete to permit a substantive review.

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 3 September 2018 to communicate proposed labeling and, if necessary, any postmarketing requirement/commitment requests.

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