Vitekta

NDA 203093, held by Gilead Sciences Inc. Elvitegravir.

As of Nov 13, 2026, NDA 203093 (Vitekta), held by Gilead Sciences Inc, was first approved by FDA on Sep 24, 2014, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 24, 2014
Review: Standard
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
Sep 24, 2014	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Vitekta85MG · tablet;oral	Elvitegravir	DiscontinuedReference drug
Vitekta150MG · tablet;oral	Elvitegravir	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Jan 21, 2016	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 27, 2015	Supplement 2Labeling · Standard review	Approved	Label Letter
Jul 16, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 24, 2014	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 203093
Drugs@FDA: Overview at FDA
Company: Gilead Sciences

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