Treats chronic hepatitis C (CHC) virus infection. ANDA 79111, held by Aurobindo Pharma. Ribavirin.
As of Nov 14, 2026, ANDA 79111 (Ribavirin), held by Aurobindo Pharma, was first approved by FDA on Sep 17, 2009, with 5 approved supplements and 0 published complete response letters.
Ribavirin tablets in combination with PEGASYS (peginterferon alfa-2a) are indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha. The following points should be considered when initiating ribavirin tablets combination therapy with PEGASYS: This indication is based on clinical trials of combination therapy in patients with CHC and compensated liver disease, some of whom had histological evidence of cirrhosis (Child-Pugh class A), and in adult patients with clinically stable HIV disease and CD4 count greater than 100 cells/mm 3.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2009 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ribavirin200MG · tablet;oral | Ribavirin | Rx |
| Apr 19, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jan 6, 2016 | Supplement 4Labeling | Approved | None posted |
| Jan 6, 2016 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jan 6, 2016 | Supplement 7Labeling · Standard review | Approved | None posted |
| Mar 16, 2011 | Supplement 1Labeling | Approved | None posted |
| Sep 17, 2009 | Original application | Approved | None posted |
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
