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  4. CBER-Regulated Products: Permanent Discontinuations
  1. Safety & Availability (Biologics)

CBER-Regulated Products: Permanent Discontinuations

How does CBER Learn about the Discontinuation of the Products It Regulates?

FDASIA requires manufacturers of certain drug products to notify FDA at least 6 months prior to the date of the permanent discontinuance in the manufacture of the drug or an interruption in the manufacturing of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, or, if that is not possible, as soon as practicable. Such drug products include those that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery. FDASIA excludes radiopharmaceutical products.

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 Permanently Discontinued CBER-Regulated Products

Product Manufacturer Manufacturer Contact Information Additional Information Discontinued Date
Hepatitis B
Vaccine
(Recombinant)
PreHevbrio®

NDC Number:
75052-001-01

1.0mL single-
dose vial

NDC Number:
75052-001-10

10 X 1.0mL
single-dose vials		 VBI Vaccines (Delaware) Inc.

prehevbrio@vbivaccines.com
or
1-888-421-8808

VBI Vaccines (Delaware) Inc., has discontinued the manufacture of PreHevbrio (Hepatitis B Vaccine, Recombinant), and has voluntarily withdrawn all products from the market, due to the bankruptcy of the company and the termination of its operations. The market withdrawal of PreHevbrio by VBI Vaccines Inc. is not due to safety or effectiveness concerns with the vaccine.

Because of the company’s discontinuation of operations, any remaining PreHevbrio should not be used or further distributed, and any existing vials of vaccine should be destroyed immediately in accordance with applicable law. The company has requested notification of vaccine disposition to prehevbrio@vbivaccines.com.

More information may be found at the links below: https://www.prehevbrio.com/

https://www.fda.gov/vaccines-blood-biologics/prehevbrio

For those who have initiated the three-dose series of PreHevbrio, but have not completed the series, please refer to the CDC recommendations for guidance on completing the series.

Potential adverse reactions or possible side effects experienced with the use of PreHevbrio may be reported either online Vaccine Adverse Event Reporting System (VAERS)., by fax, or by regular mail.

VAERS
P.O. Box 1100
Rockville, MD, 20849-1100

If you require assistance with reporting, you can contact VAERS by email at info@vaers.org or by phone at 1-800-822-7967

 Discontinued:
November 2024
Pharmalgen® (lyophilized allergenic venom extract)

(Please See Additional Information Section)		 ALK - Abello A/S 1-512-251-0037 ALK - Abello A/S., has discontinued the manufacture of, and has requested a voluntary revocation of their biologics licenses for the following products:

Venoms, Honey Bee Venom, Pharmalgen®
NDC Number: 52709-0801-1
1.2 mL in 1 VIAL, SINGLE-DOSE

Venoms, Mixed Vespid Venom Protein, Pharmalgen®
NDC Number: 52709-1201-1
1.2 mL in 1 VIAL, SINGLE-DOSE

Venoms, Wasp Venom Protein, Pharmalgen®
NDC Number: 52709-1301-1
1.2 mL in 1 VIAL, SINGLE-DOSE

Venoms, White Faced Hornet Venom Protein, Pharmalgen®
NDC Number: 52709-1101-1
1.2 mL in 1 VIAL, SINGLE-DOSE

Venoms, Yellow Hornet Venom Protein, Pharmalgen®
NDC Number: 52709-1001-1
1.2 mL in 1 VIAL, SINGLE-DOSE

Venoms, Yellow Jacket Venom Protein, Pharmalgen®
NDC Number: 52709-0901-1
1.2 mL in 1 VIAL, SINGLE-DOSE		 Discontinued:
August 1, 2023
Multiple Allergenic Products
(Please See Additional Information Section) 		Allergy Laboratories, Inc. 1-800-325-7354 Allergy Laboratories, Inc., has discontinued the manufacture of, and has requested a voluntary revocation of their biologics licenses for the following products:
  • BL 101376 – Multiple Products: Non-Standardized Allergenics
  • BL 101377 – Insects (Whole Body), Mite Dermatophagoides farina
  • BL 101378 – Insect (Whole Body), Mite Dermatophagoides pteronyssinus
  • BL 101379 – Pollens – Grasses, Bermuda Grass Cynodon dactylon
  • BL 101380 – Pollens – Grasses, Blue Grass, Kentucky (June) pratensis
  • BL 101381 – Pollens – Grasses, Fescue, Meadow Festuca elatior
  • BL 101382 – Pollens – Grasses, Orchard Grass Dactylis glomerata
  • BL 101383 – Pollens – Grasses, Redtop Agrostis alba
  • BL 101384 – Pollens – Grasses, Ryegrass, Perennial Lolium perenne
  • BL 101385 – Pollens – Grasses, Sweet Vernal Grass, Anthoxanthum odoratum
  • BL 101386 – Pollens – Grasses, Timothy Phleum pratense
  • BL 101387 – Pollens – Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia
  • BL 103324 – Animal Allergens, Standardized Cat Hair

Please see attached spreadsheet containing complete listing of NDC numbers for all products that have been discontinued.

 Discontinued: February 22, 2023
BCG Live (Intravesical)
TheraCys®

NDC Number:
49281-880-03

81 mg lyophilized powder		 Sanofi Pasteur, Ltd. 1-800-VACCINE
(1-800-822-2463)		 BCG Live (Intravesical) TheraCys®, indicated for the treatment of non-muscle invasive bladder cancer, has been discontinued. Discontinued:
November 2016
Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic)(RIBA) CHIRON® RIBA® HCV 3.0 Strip Immunoblot Assay (SIA)

Product Code: 930600		 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
Rubella Virus Vaccine Live
Meruvax II®

NDC Number:
0006-4673-00
0.5 mL 10 dose vials		 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
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

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