Vitrasert

NDA 20569, held by Bausch And Lomb. Ganciclovir.

As of Nov 13, 2026, NDA 20569 (Vitrasert), held by Bausch And Lomb, was first approved by FDA on Mar 4, 1996, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 4, 1996
Review: Priority
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Mar 4, 1996	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vitrasert4.5MG · implant;implantation	Ganciclovir	Discontinued

All 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 18, 2000	Supplement 6Manufacturing	Approved	None posted
Aug 4, 1999	Supplement 5Manufacturing	Approved	None posted
May 14, 1999	Supplement 4Manufacturing	Approved	None posted
Nov 26, 1997	Supplement 3Manufacturing	Approved	None posted
Oct 17, 1997	Supplement 2Manufacturing	Approved	None posted
Dec 20, 1996	Supplement 1Manufacturing	Approved	None posted
Mar 4, 1996	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 20569
Drugs@FDA: Overview at FDA
Company: Bausch & Lomb

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