Adamis Pharmaceuticals Announces FDA Acceptance for Review for the Supplemental New Drug Application

- February 13th, 2018

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 … Continued

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.

Click here to read the full press release.

Are You Aware of the FDA's Plans for 2018?

Find out what's going on in our new report
 

Leave a Reply

Your email address will not be published. Required fields are marked *