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Voquezna Dual Pak FDA Approval History

Last updated by Judith Stewart, BPharm on July 15, 2024.

FDA Approved: Yes (First approved May 3, 2022)
Brand name: Voquezna Dual Pak
Generic name: amoxicillin and vonoprazan
Dosage form: Co-Packaged Capsules and Tablets
Company: Phathom Pharmaceuticals, Inc.
Treatment for: Helicobacter Pylori Infection

Voquezna Dual Pak (amoxicillin and vonoprazan) is a co-packaged product containing amoxicillin (penicillin class antibacterial) and vonoprazan (potassium-competitive acid blocker (PCAB)) indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults.

 

Development timeline for Voquezna Dual Pak

DateArticle
Oct 31, 2023Approval Phathom Pharmaceuticals Announces FDA Approval of Reformulated Vonoprazan Tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adults
May  4, 2022Approval FDA Approves Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adults
Apr 29, 2021Phathom Pharmaceuticals Announces Positive Topline Results from Pivotal Phase 3 Trial of Vonoprazan in Helicobacter pylori (H. pylori) Infection; Study Met All Primary and Secondary Endpoints
Dec 23, 2019Phathom Pharmaceuticals Announces Initiation of Pivotal Phase 3 Clinical Trial for Vonoprazan in Helicobacter Pylori (H. pylori) Infection

Further information

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