Bevyxxa

NDA 208383, held by Portola Pharms Inc. Betrixaban.

As of Nov 13, 2026, NDA 208383 (Bevyxxa), held by Portola Pharms Inc, was first approved by FDA on Jun 23, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 23, 2017
Review: Priority
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 23, 2017	Original applicationNew molecular entity · Priority review	Approved	Review Label Medication Guide Letter

Products

2 strengths and forms


Bevyxxa40MG · capsule;oral	Betrixaban	DiscontinuedReference drug
Bevyxxa80MG · capsule;oral	Betrixaban	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Aug 24, 2020	Supplement 7Labeling · Standard review	Approved	Label Letter
Jul 18, 2019	Supplement 6Labeling · Standard review	Approved	Label Letter
Jul 14, 2017	Supplement 1Labeling · Standard review	Approved	Letter Label
Jun 23, 2017	Original applicationNew molecular entity · Priority review	Approved	Review Label Medication Guide Letter

Identifiers

Application: NDA 208383
Drugs@FDA: Overview at FDA
Company: Portola Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters