Vaccines, Blood & Biologics
Resources for You
Complete List of Licensed Products and Establishments Complete List of Vaccines Licensed for Immunization and Distribution in the US Complete List of Currently Approved NDA and ANDA Application Submissions(PDF - 17KB) Complete List of Currently Approved Premarket Approvals (PMAs)(PDF - 19KB) Complete List of Substantially Equivalent 510(k) Device Applications(PDF - 334KB)
- CDC's Recommended Immunization Schedules for Adults and Children
Office of Compliance and Biologics Quality (OCBQ)
CBER-Regulated Products: Discontinuations
How does CBER Learn about the Discontinuation of the Products It Regulates?
Manufacturers of CBER-regulated products often voluntarily notify CBER of the discontinuation of a product that they manufacture when the product does not meet the requirements for notification under FDASIA. In addition, manufacturers of CBER-regulated drug products approved under new drug applications (NDAs) and abbreviated new drug applications (ANDAs) are required under 21 CFR 314.81(b)(3)(iii) to provide FDA with a six month advance notice of the discontinuation of sole source products that are life-supporting, life-sustaining or for use in the prevention of a debilitating disease or condition.
In certain circumstances, CBER-regulated products may also be discontinued from marketing by the manufacturer, but are still licensed without being assessed product user fees. These products are identified on CBER's User Fee Billable Biologic Products / Discontinued List. After clicking on this link, you must scroll to bottom of that webpage to view a second table containing the list of CBER discontinued products that are no longer being assessed product user fees.
The table below lists only those CBER-regulated products which the manufacturer has permanently discontinued and, as a result of, CBER has determined may likely lead to a meaningful disruption in the supply of that product in the United States. This table is for informational purposes only.
Tabular Listing of Discontinued CBER-Regulated Products
Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic)(RIBA) CHIRON® RIBA® HCV 3.0 Strip Immunoblot Assay (SIA)
Ortho-Clinical Diagnostics, Inc. – Customer Technical Services
Novartis Diagnostics, the legal manufacturer of this immunoblot assay, has informed the FDA that the production of the CHIRON® RIBA® HCV 3.0 Strip Immunoblot Assay (SIA) has been discontinued.
Product Code: 930600
Rubella Virus Vaccine Live
Merck & Co., Inc.
MERUVAX® II (Rubella Virus Vaccine Live) has been discontinued.
The Advisory Committee on Immunization Practices (ACIP) has recommended the use of combined measles-mumps-rubella vaccine (M-M-R® II - Measles, Mumps, and Rubella Virus Vaccine Live) for appropriate individuals to help protect against measles, mumps, and rubella.
0.5 mL 10 dose vials
Varicella Zoster Immune Globulin (Human)
MPHBL has discontinued manufacture of VZIG and a limited supply of VZIG remains.
FFF Enterprises (Temecula, CA) the sole authorized distributor of the product, will assist in determining patient eligibility and in shipping investigational VZIG.
February 10, 2006