Invirase

NDA 21785, held by Hoffmann-La Roche. Saquinavir Mesylate.

As of Nov 14, 2026, NDA 21785 (Invirase), held by Hoffmann-La Roche, was first approved by FDA on Dec 17, 2004, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 17, 2004
Review: Priority
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Nov 30, 2012	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 17, 2004	Original applicationNew dosage form · Priority review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
InviraseEQ 500MG BASE · tablet;oral	Saquinavir Mesylate	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements


Sep 18, 2020	Supplement 25Labeling · Standard review	Approved	Label Medication Guide Letter
Dec 19, 2019	Supplement 24Labeling · Standard review	Approved	Letter Label Medication Guide
Mar 28, 2019	Supplement 23Labeling · Standard review	Approved	Medication Guide Label Letter
Mar 15, 2018	Supplement 22Labeling · Standard review	Approved	Medication Guide Letter Label
Sep 15, 2016	Supplement 21Labeling	Approved	Label Letter
Feb 26, 2016	Supplement 17Labeling · Standard review	Approved	Label Letter
Dec 16, 2015	Supplement 19Labeling · Standard review	Approved	Label Letter
Apr 21, 2015	Supplement 16Labeling · Standard review	Approved	Label Letter
Mar 27, 2015	Supplement 18Labeling	Approved	Label Letter
Nov 30, 2012	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 17, 2012	Supplement 15Labeling	Approved	Letter Label
May 26, 2011	Supplement 14REMS	Approved	Letter
Oct 6, 2010	Supplement 10Labeling · Standard review	Approved	Letter Label
Apr 27, 2010	Supplement 9Labeling	Approved	Label Letter
Jan 21, 2010	Supplement 6Labeling · Standard review	Approved	Letter Label
Jul 11, 2007	Supplement 4Labeling · Standard review	Approved	Letter Label
Apr 3, 2007	Supplement 3Labeling · Standard review	Approved	Letter Label
Sep 8, 2005	Supplement 2Labeling · Standard review	Approved	Review Patient Package Insert Letter Label
Sep 8, 2005	Supplement 1Labeling · Standard review	Approved	Patient Package Insert Label Letter
Dec 17, 2004	Original applicationNew dosage form · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 21785
Drugs@FDA: Overview at FDA
Company: Hoffmann-La Roche

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