FDA rejects Australian Dairy Nutritionals’ (ASX:AHF) application to sell infant formula range

• The US Food and Drug Administration (FDA) rejects Australian Dairy Nutritionals’ (AHF) application to sell its ‘future’ infant formula in the States
• The company says the FDA’s temporary accelerated approval process was only available for supply until November 14
• However, the FDA has encouraged AHF to apply for the registration of its future-branded infant formula range through the normal registration process
• Shares in Australian Dairy Nutritionals are down 7.02 per cent and trading at 5.3 cents at 2:53 pm AEDT

The US Food and Drug Administration (FDA) has rejected Australian Dairy Nutritionals’ (AHF) application to sell its ‘future’ infant formula in the States.

The company said FDA’s temporary accelerated approval process was only available for supply until November 14.

However, the FDA has encouraged AHF to apply for the registration of its future-branded infant formula range through the normal registration process.

AHF first submitted its application for accelerated approval in May and confirmed its board was working with both Australian and American authorities to progress supply opportunities in the US market.

The expedited pathway to approval was opened following a critical shortage of baby formula across the US after one of the country’s top baby formula makers, Abbott Laboratories, closed its manufacturing plant.

Looking ahead, AHF said it was “advanced” in preparing its toddler milk for launch in the US next year.

Shares in Australian Dairy Nutritionals were down 7.02 per cent and trading at 5.3 cents at 2:53 pm AEDT.