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Voquezna Triple Pak FDA Approval History

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

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

  • The Voquezna Triple and Dual Paks offer physicians the flexibility of two different treatment options. The Voquezna Triple Pak contains clarithromycin that is not included in the Voquezna Dual Pak.

Development Timeline for Voquezna Triple 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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