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Erwinase
  • Professionals
  • FDA PI

Erwinase

Generic name: asparaginase
Dosage form: injection, powder, lyophilized, for solution
Drug class:Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on Jun 1, 2021.

HEALTH CARE PROVIDER LETTER

25 May 2021

IMPORTANT PRESCRIBING INFORMATION

Subject: Temporary importation of Erwinase® (crisantaspase) injection, powder, lyophilized, for solution to address a drug shortage in the United States (U.S.)

Dear Healthcare Professional,

In order to alleviate a critical shortage of U.S.-licensed asparaginase erwinia chrysanthemi injection, powder, lyophilized, for solution in the US market, Porton Biopharma Limited (PBL) is coordinating with the U.S. Food and Drug Administration (FDA) to make available in the U.S. the non-FDA licensed Erwinase (crisantaspase) 10,000 IU/vial powder for solution for injection/infusion.

At this time, no other entity except PBL (via its distributor Clinigen Inc.) is authorized by the FDA to import and distribute Erwinase in the U.S. However, this does not represent a formal FDA approval of Erwinase in the U.S.

Effective immediately, PBL (via its distributor Clinigen Inc.) will distribute the following presentation of Erwinase (Batch number: W060172) to address the critical shortage:

Product Name

Pack Size

Description

U.K. Marketing Authorization Number

NDC

Erwinase, 10,000 IU/vial, Powder for solution for injection/infusion.

5 vials

Powder for solution for injection/infusion. White lyophilised powder in a vial.

PL 44403/0002

NDC 81561-413-05*

*This NDC code has been assigned by PBL. The code is presented on the carton. It should be noted that the importer and distributor in the U.S. will be Clinigen Inc. The same NDC code will be used throughout the distribution chain of the product in the U.S.

It is important to note the following:

  • Erwinase is available ...