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Voquezna Dual Pak FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 23, 2022.

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.

  • Voquezna Dual Pak contains vonoprazan, a novel, first-in-class potassium-competitive acid blocker (PCAB) that works to block acid secretion in the stomach. Vonoprazan is currently approved in combination with antibiotics (Voquezna Dual Pak and Voquezna Triple Pak) for the treatment of Helicobacter pylori (H. pylori) infection. The Voquezna Dual Pak contains amoxicillin and vonoprazan, and the Voquezna Triple Pak contains amoxicillin, clarithromycin, and vonoprazan. The Voquezna Dual Pak provides an alternative for patients who cannot take clarithromycin.
  • Voquezna Dual Pak contains amoxicillin 500 mg capsules and vonoprazan 20 mg tablets. The recommended dosage regimen is two amoxicillin 500 mg capsules three times a day (morning, mid-day, and evening) and one vonoprazan 20 mg tablet twice daily (morning and evening), with or without food, for 14 days.
  • Warnings and precautions associated with Voquezna Dual Pak include hypersensitivity reactions; severe cutaneous adverse reactions (SCAR); and clostridioides difficile-associated diarrhea (CDAD).
  • Common adverse reactions include diarrhea, abdominal pain, vulvovaginal candidiasis and nasopharyngitis.


Development timeline for Voquezna Dual Pak

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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