APO-VARENICLINE- varenicline kit APO-VARENICLINE- varenicline tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

VARENICLINE TARTRATE (UNII: 82269ASB48) (VARENICLINE - UNII:W6HS99O8ZO)

Διαθέσιμο από:

Apotex Corp

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

Unapproved drug for use in drug shortage

Αρχείο Π.Χ.Π.

APO-VARENICLINE- VARENICLINE
APO-VARENICLINE- VARENICLINE TABLET, FILM COATED
APOTEX CORP
_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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APO-VARENICLINE TABLETS
HEALTH CARE PROVIDER LETTER
IMPORTANT PRESCRIBING INFORMATION
July 2, 2021
Apotex Corp.
2400 N Commerce Parkway
Suite 400
Weston, FL 33326
Phone: [phone]
SUBJECT: IMPORTATION OF APOTEX INC.’S CANADIAN APPROVED
APO-VARENICLINE
(VARENICLINE TARTRATE) 0.5 MG AND 1 MG (BASED ON FREE BASE
EQUIVALENTS)
TABLETS TO ADDRESS DRUG SHORTAGE
Dear Healthcare Professional:
In order to alleviate a critical shortage of CHANTIX (varenicline
tartrate) tablets 0.5 mg
and 1 mg in the United States (U.S.) market for the indicated use as
an aid to smoking
cessation, Apotex Corp. is coordinating with the U.S. Food and Drug
Administration
(FDA) to temporarily import into the U.S. the non-FDA approved drug,
Apo-Varenicline
(varenicline tartrate) 0.5 mg and 1 mg (free base equivalent) tablets
to increase the
availability of the drug. The varenicline tartrate tablets marketed in
Canada under the
name Apo-Varenicline by Apotex Inc. are approved by Health Canada as a
generic
equivalent to CHAMPIX tablets manufactured by Pfizer Canada, Inc., and
are
manufactured in an FDA-inspected facility that complies with current
Good
Manufacturing Practice (cGMP) requirements.
At this time, no other entity except Apotex Corp. is authorized by the
FDA to import or
distribute Apotex Inc.’s Apo-Varenicline (varenicline tartrate) 0.5
mg and 1 mg (free
base equivalent) tablets in the U.S. However, this does not represent
a formal FDA
approval of Apotex Inc.’s Apo-Varenicline (varenicline tartrate)
tablets in the United
States.
Effective immediately, Apotex Corp. will distribute the following
presentations of Apotex
Inc.’s Apo-Varenicline (varenicline tartrate) tablets to address the
critical shortage:
Table 1
PRODUCT
NAME
QUANTITY
TABLET