EXTENCILLINE- benzathine benzylpenicillin kit EXTENCILLINE- benzathine benzylpenicillin injection, powder, for suspension

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

PENICILLIN G BENZATHINE (UNII: RIT82F58GK) (PENICILLIN G - UNII:Q42T66VG0C)

Tilgjengelig fra:

Provepharm Inc.

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Unapproved drug for use in drug shortage

Preparatomtale

EXTENCILLINE- BENZATHINE BENZYLPENICILLIN
EXTENCILLINE- BENZATHINE BENZYLPENICILLIN INJECTION, POWDER, FOR
SUSPENSION
PROVEPHARM 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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EXTENCILLINE, (BENZATHINE BENZYLPENICILLIN) POWDER AND DILUENT FOR
RECONSTITUTION FOR INJECTION
HEALTH CARE PROVIDER LETTER
March 7, 2024
Laboratoires DELBERT
49 Rue Rouelle
75015 Paris
France
Phone : [phone]
https://laboratoires-delbert.fr/en/
IMPORTANT PRESCRIBING INFORMATION
SUBJECT:
TEMPORARY IMPORTATION OF EXTENCILLINE, (BENZATHINE BENZYLPENICILLIN)
POWDER AND DILUENT FOR RECONSTITUTION FOR INJECTION, 1,200,000 UNITS
AND 2,400,000 UNITS WITH FOREIGN, NON-U.S. LABELING TO ADDRESS
SUPPLY SHORTAGE
Dear Healthcare Provider,
To address the ongoing shortages of Bicillin® L-A (penicillin G
benzathine injectable
suspension) in the United States, Laboratoires Delbert in conjunction
with Provepharm
Inc. (Provepharm) and several distributors (McKesson Corporation,
Cencora Global
Procurement Ltd., Cardinal Health, Morris & Dickson and Direct Success
Inc.)
("Distributors") coordinating with the U.S. Food and Drug
Administration (FDA) to
temporarily import Extencilline, (benzathine benzylpenicillin) Powder
and diluent for
reconstitution for injection, 1,200,000 units and 2,400,000 units into
the U.S. market.
Delbert’s Extencilline, (benzathine benzylpenicillin) Powder and
diluent for reconstitution
for injection, 1,200,000 units and 2,400,000 units marketed in France
and manufactured
in Italy for Delbert, is not FDA-approved. Benzathine benzylpenicillin
is another name for
Penicillin G benzathine.
At this time, no other entity except Provepharm or its Distributors
identified in the first
paragraph are authorized by the FDA to import or distribute
Extencilline powder and
diluent for reconstitution for injection in the U.S.
Effective immediately, Provepharm will distribute the follo