Cytovene

NDA 20460, held by Roche Palo. Ganciclovir.

As of Nov 14, 2026, NDA 20460 (Cytovene), held by Roche Palo, was first approved by FDA on Dec 22, 1994, with 11 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1994
Review: Priority
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Dec 12, 1997	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Review
Nov 27, 1996	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 27, 1995	Supplement 5Efficacy (new indication or use) · Priority review	Approved	None posted
Dec 22, 1994	Original applicationNew dosage form · Priority review	Approved	None posted

Products

2 strengths and forms


Cytovene250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Ganciclovir	DiscontinuedReference drug
Cytovene500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Ganciclovir	DiscontinuedReference drug

All 12 submissions, including labeling and manufacturing supplements


Sep 13, 2002	Supplement 12Manufacturing · Priority review	Approved	None posted
Dec 1, 2000	Supplement 10Labeling · Standard review	Approved	None posted
Oct 17, 2000	Supplement 11Manufacturing · Priority review	Approved	None posted
Oct 21, 1998	Supplement 9Manufacturing · Priority review	Approved	None posted
Dec 30, 1997	Supplement 4Manufacturing · Priority review	Approved	None posted
Dec 12, 1997	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Review
May 30, 1997	Supplement 7Manufacturing · Priority review	Approved	None posted
Nov 27, 1996	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 27, 1995	Supplement 5Efficacy (new indication or use) · Priority review	Approved	None posted
Jul 20, 1995	Supplement 2Manufacturing · Priority review	Approved	None posted
Mar 1, 1995	Supplement 3Labeling · Standard review	Approved	None posted
Dec 22, 1994	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 20460
Drugs@FDA: Overview at FDA
Company: Roche Palo Alto

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