MAY 8, 2023:

Our Mermaid Tears™ drug listing became active on DailyMed, the National Library of Medicine’s database. We had submitted this listing to the FDA electronically through their online system for industry’s use (CDER Direct).

JULY 7, 2023:

Bloomberg BusinessWeek shared Mermaid Tears™ with the FDA and asked for comments in preparation for publishing a story about eye drops.

JULY 14, 2023:

We received an automated notification that the FDA had inactivated our Labeler Code (used in National Drug Codes assigned to products).

This means that we are unable to submit any new drug listings. That’s okay. We think we made our point.

Interestingly, the FDA notice stated that when they inactivate a labeler code, it is because there have been no products listed on that labeler code for two years. It also states that companies whose Labeler Code is being inactivated receive a notification 30 days prior to inactivation. Neither of those things was true in our case.