Bubs Australia on track for US FDA approval

Bubs Australia (ASX:BUB) has provided an update on its progress toward permanent regulatory approval in the United States.

The company's New Infant Formula Submissions for Bubs Essential, Bubs 365 Day Grass Fed, and Bubs Goat powder infant formulas are continuing to undergo review by the US Food and Drug Administration.

Bubs confirmed it has met all information requests from the FDA, with no outstanding requirements, and remains on track to secure permanent market access.

Meanwhile, the FDA has assured that the importation, sale, and distribution of Bubs’ infant formula products in the US will continue beyond Dec. 31, under its ‘enforcement discretion’ framework.

The arrangement ensures ongoing supply to US retail partners and families relying on Bubs' products.

The company said it is working closely with the FDA to finalise permanent approval.
At the time of reporting, Bubs Australia’s share price was $0.14.