Mithracin

As of Nov 13, 2026, NDA 50109 (Mithracin), held by Pfizer, was first approved by FDA on May 5, 1970, with 1 approved supplement and 0 published complete response letters.

First approved: May 5, 1970
Review: Priority
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 5, 1970	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mithracin2.5MG/VIAL · injectable;injection	Plicamycin	Discontinued

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 8, 1999	Supplement 33Manufacturing · Priority review	Approved	None posted
May 5, 1970	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 50109
Drugs@FDA: Overview at FDA
Company: Pfizer

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