DOXORUBICIN HYDROCHLORIDE injection powder lyophilized for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXORUBICIN HYDROCHLORIDE (UNII: 82F2G7BL4E) (DOXORUBICIN - UNII:80168379AG)

Available from:

Hospira, Inc.

INN (International Name):

DOXORUBICIN HYDROCHLORIDE

Composition:

DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Unapproved drug for use in drug shortage

Summary of Product characteristics

DOXORUBICIN HYDROCHLORIDE- DOXORUBICIN HYDROCHLORIDE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
HOSPIRA, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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DOXORUBICIN HYDROCHLORIDE
HEALTH CARE PROVIDER LETTER
IMPORTANT DRUG INFORMATION
SUBJECT:
TEMPORARY IMPORTATION OF DOXORUBICIN HYDROCHLORIDE 50 MG POWDER FOR
INJECTION
(50 MG/VIAL) TO ADDRESS DRUG SHORTAGE ISSUE
April 18, 2016
Dear Health Care Provider,
Due to the current critical shortage of Doxorubicin Hydrochloride for
Injection, USP in the United
States (U.S.) market, Hospira, Inc., a Pfizer company (Hospira), is
coordinating with the U.S. Food and
Drug Administration (FDA) to increase the availability of the drug.
Hospira has initiated temporary
importation of non-U.S. approved product, Doxorubicin Hydrochloride 50
mg Powder for Injection
from Hospira Limited, United Kingdom (Hospira Limited): Lot DO21502A,
expiration 12/2017.
The Doxorubicin Hydrochloride 50 mg Powder for Injection from Hospira
Limited is manufactured by
Zydus Hospira Oncology Private Limited (ZHOPL) in Ahmedabad, India, at
an FDA-inspected facility
that is in compliance with current good manufacturing practice
requirements.
At this time, no other entity except Hospira Limited or their
distributor Hospira is authorized by the
FDA to import or distribute Doxorubicin Hydrochloride 50 mg Powder for
Injection in the U.S. FDA
has not approved Hospira Limited’s Doxorubicin Hydrochloride 50 mg
Powder for Injection (50
mg/vial) product in the U.S.
Effective immediately, and during this temporary period, Hospira will
offer the following presentation
of Doxorubicin Hydrochloride for Injection:
PRODUCT
STRENGTH
SIZE
MARKETING AUTHORIZATION #
DOXORUBICIN HYDROCHLORIDE
50 mg Powder for Injection
50 mg/vial
Box of 1 vial
PL 4515/0073
(United Kingdom)
The barcode used for Hospira Limited’s non-U.S. approved Doxorubicin
Hydrochloride 50 mg
Powder fo