Posted by Michael Wonder on 12 Feb 2018
Adamis Pharmaceuticals announces FDA acceptance for review for the supplemental new drug application of its low dose Symjepi product candidate
12 February 2018 - Adamis Pharmaceuticals Corporation today announced that the U.S. FDA has accepted for review the company’s supplemental new drug application for its low dose Symjepi product candidate for the emergency treatment of anaphylaxis.
On 9 February 2018, Adamis received FDA correspondence relating to the company’s application stating that the Agency had completed their filing review and had determined that the application 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 labelling and, if necessary, any post-marketing requirement/commitment requests.
