Phathom Pharmaceuticals today debuted its first effort for erosive esophagitis treatment Voquezna with a splashy direct-to-consumer campaign including a telehealth option.
National TV and digital media campaign aims to motivate millions of people suffering from Erosive GERD to learn more about VOQUEZNA® (vonoprazan), the first and only FDA-approved potassium-competitive acid blocker (PCAB)
One of the largest pharmacy benefit management (PBM) companies in the United States has added VOQUEZNA (vonoprazan) tablets to its national formularies for commercial plans, effective immediately ...
New drug application (NDA) seeks U.S. Food and Drug Administration (FDA) approval for VOQUEZNA® as a daily treatment for heartburn associated with Non-Erosive GERD, the largest subcategory of GERDJuly...
VOQUEZNA, the first and only FDA-approved potassium-competitive acid blocker (PCAB), is now available at major retail pharmacies and through BlinkRx.
US approves Phathom`s Voquezna for erosive GERD
Planning for a December 2023 U.S. launch for H. pylori, together with the U.S. launch of vonoprazan for Erosive GERD, if approved FLORHAM PARK, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Phathom...
A meeting with the FDA has paved the way for Phathom Pharmaceuticals to resubmit its applications for its erosive esophagitis and Helicobacter pylori drug Voquezna, the company said on Tuesday.
The FDA issued complete response letters to Phathom Pharmaceuticals, flagging the presence of N-nitroso-vonoprazan (NVP) impurities detected in the company’s approved Helicobacter pylori drug products, the company announced Thursday.
The FDA has formally asked for additional stability data to demonstrate that levels of the impurity previously found in Phathom Pharmaceuticals Inc's (NASDAQ: PHAT) vonoprazan drug product will remain at or below the daily acceptable intake throughout the proposed shelf life of the product.