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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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. 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. The table below is for informational purposes only.
  
Tabular Listing of Discontinued CBER-Regulated Products

 

Product

Manufacturer

Manufacturer
Contact Information

Additional Information

Discontinued
Date

Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic)(RIBA) CHIRON® RIBA® HCV 3.0 Strip Immunoblot Assay (SIA)

 

Manufactured by:
Novartis Diagnostics  
Distributed by:
Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc. – Customer Technical Services
1-800-421-3311

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. 

FDA regulations provide procedures for licensed and unlicensed blood establishments wishing to obtain an exception or alternative procedure to the requirements in Parts 600-680. 

Additional information concerning this product and instructions for obtaining an exception or alternative procedure can be found at:

CBER Safety and Availability webpage

and  

Information for Blood Establishments: DISCONTINUATION of CHIRON® RIBA® HCV 3.0 SIA (RIBA)

and

Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (July 2001)

Discontinued:
February 18, 2013
 

Product Code: 930600
 

Rubella Virus Vaccine Live
Meruvax II®

Merck & Co., Inc.

1-800-NSC-MERCK
(1-800-672-6372)

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.

Discontinued:
May 24, 2011
 

NDC Number:
0006-4673-00

0.5 mL 10 dose vials 

Varicella Zoster Immune Globulin (Human)
VZIG

 

Manufactured by:
Massachusetts Public Health Biologic Laboratories (MPHBL)

Distributed by:
FFF Enterprises

FFF Enterprises:

1-800-843-7477

MPHBL has discontinued manufacture of VZIG and a limited supply of VZIG remains.

Investigational (not licensed) VZIG product is available under an investigational new drug application (IND) protocol.

FFF Enterprises (Temecula, CA) the sole authorized distributor of the product, will assist in determining patient eligibility and in shipping investigational VZIG.

Discontinued:

February 10, 2006
 

 

Contact FDA

240-402-8380
Biological Product Shortages