Fortovase

NDA 20828, held by Hoffmann La Roche. Saquinavir.

As of Nov 13, 2026, NDA 20828 (Fortovase), held by Hoffmann La Roche, was first approved by FDA on Nov 7, 1997, with 13 approved supplements and 0 published complete response letters.

First approved: Nov 7, 1997
Review: Priority
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Dec 24, 2003	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Review Patient Package Insert Label Letter
Nov 7, 1997	Original applicationNew dosage form · Priority review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fortovase200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Saquinavir	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Sep 8, 2005	Supplement 19Labeling · Priority review	Approved	Review Patient Package Insert Letter Label
Sep 8, 2005	Supplement 20Labeling · Priority review	Approved	Review Patient Package Insert Letter Label
Dec 24, 2003	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Review Patient Package Insert Label Letter
Jul 2, 2002	Supplement 10Labeling · Priority review	Approved	Letter Label
Mar 28, 2002	Supplement 11Manufacturing · Priority review	Approved	None posted
Nov 13, 2000	Supplement 8Labeling · Priority review	Approved	None posted
Sep 22, 2000	Supplement 9Manufacturing · Priority review	Approved	None posted
Sep 8, 1999	Supplement 7Manufacturing · Priority review	Approved	None posted
Mar 18, 1999	Supplement 6Manufacturing · Priority review	Approved	Review
Feb 12, 1999	Supplement 4Manufacturing · Priority review	Approved	None posted
Dec 4, 1998	Supplement 5Manufacturing · Priority review	Approved	None posted
Sep 9, 1998	Supplement 2Manufacturing · Priority review	Approved	None posted
Aug 5, 1998	Supplement 1Labeling · Priority review	Approved	None posted
Nov 7, 1997	Original applicationNew dosage form · Priority review	Approved	Review

Identifiers

Application: NDA 20828
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