Intron A (interferon alfa-2b)

BL 103132

Intron A (interferon alfa-2b)

BL 103132

U.S. License Holder:

Schering

Date of License:

June-04-1986

Last Update:

December-09-2018

approved_indications FDA-Approved Indications


INTRON A (interferon alfa-2b) is indicated for:

Hairy Cell Leukemia: for the treatment of patients 18 years of age or older with hairy cell leukemia;

Malignant Melanoma: as adjuvant to surgical treatment in patients 18 years of age or older with malignant melanoma who are free of disease but at high risk for systemic recurrence, within 56 days of surgery;

Follicular Lymphoma: for the initial treatment of clinically aggressive follicular Non-Hodgkin's Lymphoma in conjunction with anthracycline-containing combination chemotherapy in patients 18 years of age or older;

Condylomata Acuminata: for intralesional treatment of selected patients 18 years of age or older with condylomata acuminata involving external surfaces of the genital and perianal areas;

AIDS-Related Kaposi's Sarcoma: for the treatment of selected patients 18 years of age or older with AIDS-Related Kaposi's Sarcoma;

Chronic Hepatitis C: for the treatment of chronic hepatitis C in patients 18 years of age or older with compensated liver disease who have a history of blood or blood-product exposure and/or are HCV antibody positive; in combination with REBETOL for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with alpha interferon therapy and in patients 18 years of age and older who have relapsed following alpha interferon therapy;

Chronic Hepatitis B: for the treatment of chronic hepatitis B in patients 1 year of age or older with compensated liver disease.

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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