More antibiotics on the way as US regulator approves reformulation

2 November 2023

Phathom Pharmaceuticals (Nasdaq: PHAT) has received approval from the US regulator for a reformulation of its oral vonoprazan products.

The nod covers the antibiotics Voquenza Triple Pak (vonoprazan/amoxicillin/clarithromycin) and Voquenza Dual Pak (vonoprazan/amoxicillin), which are used to treat Helicobacter pylori infection in adults.

The decision relates to a Prior Approval Supplement (PAS), a regulatory determination regarding a proposed change to the manufacture or testing of a product.

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