ZINC INJECTABLE A 1MG/ML, SOLUTION INJECTABLE POUR PERFUSION- zinc injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC GLUCONATE TRIHYDRATE (UNII: F2F0XU34WQ) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Laboratoire Aguettant

INN (International Name):

ZINC GLUCONATE TRIHYDRATE

Composition:

ZINC CATION 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Unapproved drug for use in drug shortage

Summary of Product characteristics

ZINC INJECTABLE A 1MG/ML, SOLUTION INJECTABLE POUR PERFUSION-
ZINC INJECTION, SOLUTION
LABORATOIRE AGUETTANT
_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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ZINC INJECTABLE A 1MG/ML, SOLUTION INJECTABLE POUR PERFUSION
DEAR HEALTHCARE PROVIDER LETTER
LABORATOIRE AGUETTANT 1 Rue Alexander Fleming 69007 LYON - FRANCE
IMPORTANT DRUG INFORMATION
ZINC INJECTION AVAILABILITY
July 23, 2013
SUBJECT: TEMPORARY IMPORTATION OF ZINC INJECTABLE 1 MG/ML (ZINC
GLUCONATE TRIHYDRATE) SOLUTION
FOR INFUSION (EQUIVALENT TO ELEMENTAL ZINC 1 MG/ML)
Dear Healthcare Professional,
Due to the current critical shortage of zinc injection drug products
in the United States (U.S.),
Laboratoire Aguettant (Aguettant) is coordinating with the Food and
Drug Administration (FDA) to
increase the availability of these products. Aguettant has initiated
temporary importation into the U.S.,
through its U.S. distributor Baxter Healthcare Corporation, the
non-FDA-approved zinc-containing
drug, ZINC INJECTABLE 1 MG/ML (ZINC GLUCONATE TRIHYDRATE) SOLUTION FOR
INFUSION (EQUIVALENT TO
ELEMENTAL ZINC 1 MG/ML): Lot T-7506C, expiration date 02-2015, and Lot
T-7519C, expiration date
03-2015.This product is marketed in France, and is manufactured for
Aguettant at a FDA-inspected
facility in France that is in compliance with Good Manufacturing
Practices (GMP) regulations enforced
in Europe.
At this time, FDA's regulatory discretion for the importation and
distribution of Aguettant's ZINC
INJECTABLE 1 MG/ML (ZINC GLUCONATE TRIHYDRATE) SOLUTION FOR INFUSION
(EQUIVALENT TO ELEMENTAL ZINC 1
MG/ML) is limited to Aguettant and its distributor Baxter Healthcare
Corporation during the critical
shortage of zinc injection. Importation and distributionof this
product in the United States byany entity
other than Aguettant and its distributor Baxter Healthcare Corporation
is outside the scope of FDA's
regulatory discretion, and FDA