Pegasys

Treats Chronic Hepatitis C (CHC) Adult Patients. BLA 103964, held by Pharmaand GmbH. Peginterferon Alfa-2a.

As of Nov 14, 2026, BLA 103964 (Pegasys), held by Pharmaand GmbH, was first approved by FDA on Oct 16, 2002, with 32 approved supplements and 0 published complete response letters.

First approved: Oct 16, 2002
Review: Standard
Supplements approved: 32
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PEGASYS is an inducer of the innate immune response indicated for the treatment of Chronic Hepatitis C (CHC) Adult Patients: In combination therapy with other hepatitis C virus drugs for adults with compensated liver disease. PEGASYS monotherapy is indicated only if patient has contraindication or significant intolerance to other HCV drugs.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below


Dec 11, 2023	Supplement 5276Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Oct 13, 2017	Supplement 5270Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 29, 2011	Supplement 5204Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 22, 2011	Supplement 5213Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 9, 2011	Supplement 5186Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 27, 2011	Supplement 5184Efficacy (new indication or use) · Standard review	Approved	Label
May 13, 2005	Supplement 5037Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 25, 2005	Supplement 5039Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 3, 2002	Supplement 5000Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 16, 2002	Original applicationNew molecular entity · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review

Products

2 strengths and forms


Pegasys180UG/VIAL · vial; subcutaneous	Peginterferon Alfa-2a	Rx
Pegasys180U/5ML · syringe	Peginterferon Alfa-2a	Rx

All 33 submissions, including labeling and manufacturing supplements


Dec 11, 2023	Supplement 5276Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Mar 24, 2021	Supplement 5275Labeling · Standard review	Approved	Letter Label
Oct 15, 2020	Supplement 5273Labeling · Standard review	Approved	Letter Label
Oct 13, 2017	Supplement 5270Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 18, 2015	Supplement 5264Labeling · Standard review	Approved	Letter Label
Sep 5, 2014	Supplement 5261Labeling · Standard review	Approved	Label Letter
Jul 2, 2013	Supplement 5245Labeling · Standard review	Approved	Label Letter
May 16, 2013	Supplement 5241Labeling · Standard review	Approved	Letter Label
Sep 29, 2011	Supplement 5204Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 22, 2011	Supplement 5213Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 9, 2011	Supplement 5186Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 27, 2011	Supplement 5184Efficacy (new indication or use) · Standard review	Approved	Label
May 9, 2011	Supplement 5216Labeling · Standard review	Approved	None posted
Feb 23, 2011	Supplement 5183Labeling · Standard review	Approved	Label Letter
May 24, 2010	Supplement 5176Labeling · Standard review	Approved	Letter
Mar 3, 2010	Supplement 5177Labeling · Standard review	Approved	Letter
Aug 7, 2009	Supplement 5171Labeling · Standard review	Approved	None posted
Apr 20, 2009	Supplement 5163Labeling · Standard review	Approved	Letter Label
Apr 20, 2009	Supplement 5147Labeling · Standard review	Approved	Letter Label
Oct 31, 2008	Supplement 5133Labeling · Standard review	Approved	Label Letter
Sep 18, 2008	Supplement 5154Labeling · Standard review	Approved	Label Letter
Jun 13, 2008	Supplement 5144Labeling · Standard review	Approved	None posted
Jun 13, 2008	Supplement 5139Labeling · Standard review	Approved	None posted
Jun 19, 2007	Supplement 5120Labeling · Standard review	Approved	Letter Label
Nov 18, 2005	Supplement 5076Labeling · Standard review	Approved	None posted
May 13, 2005	Supplement 5065Labeling · Standard review	Approved	Letter
May 13, 2005	Supplement 5057Labeling · Standard review	Approved	Letter
May 13, 2005	Supplement 5037Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 25, 2005	Supplement 5039Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 21, 2004	Supplement 5036Labeling · Standard review	Approved	Label Letter
Oct 31, 2003	Supplement 5016Labeling · Standard review	Approved	None posted
Dec 3, 2002	Supplement 5000Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 16, 2002	Original applicationNew molecular entity · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review

Identifiers

Application: BLA 103964
Drugs@FDA: Overview at FDA
Company: Pharmaand GmbH

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