Determination That AUGMENTIN `125' (Amoxicillin; Clavulanate Potassium) Chewable Tablet and Six Other AUGMENTIN (Amoxicillin; Clavulanate Potassium) Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 76016-76017 [2010-30622]
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76016
Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices
FOR FURTHER INFORMATION CONTACT:
Sean M. Boyd, Center for Devices and
Radiological Health, Office of
Communication, Education, and
Radiological Programs, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4640, Silver Spring,
MD 20993–0002, 301–796–5895.
SUPPLEMENTARY INFORMATION: In a notice
containing a cumulative list of
guidances available from the Agency
that published in the Federal Register of
August 9, 2010 (75 FR 48180 at 48233),
FDA included the Compliance Policy
Guides Manual, which includes CPG
Sec. 393.200. FDA is withdrawing CPG
Sec. 393.200 because it is obsolete.
Dated: November 23, 2010.
Dara Corrigan,
Associate Commissioner for Regulatory
Affairs.
[FR Doc. 2010–30679 Filed 12–6–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2010–P–0172 and FDA–
2010–P–0177]
Determination That AUGMENTIN ‘125’
(Amoxicillin; Clavulanate Potassium)
Chewable Tablet and Six Other
AUGMENTIN (Amoxicillin; Clavulanate
Potassium) Drug Products Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that the AUGMENTIN (amoxicillin;
clavulanate potassium) drug products
listed in this notice were not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
SUMMARY:
meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Molly Flannery, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6237,
Silver Spring, MD 20993–0002, 301–
796–3543.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the Agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug. Under § 314.161(a)(2), FDA must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness whenever a listed
drug is voluntarily withdrawn from sale
and ANDAs that refer to the listed drug
have been approved. Section 314.161(d)
provides that if FDA determines that a
listed drug was withdrawn from sale for
reasons of safety or effectiveness, the
Agency will initiate proceedings that
could result in the withdrawal of
approval of the ANDAs that refer to the
listed drug.
The drug products listed in table 1 of
this document are no longer being
marketed. Six of the products listed
(AUGMENTIN ‘125’ Chewable Tablet,
AUGMENTIN ‘250’ Chewable Tablet,
AUGMENTIN ‘200’ Powder for
Suspension, AUGMENTIN ‘400’ Powder
for Suspension, AUGMENTIN ‘200’
Chewable Tablet, and AUGMENTIN
‘400’ Chewable Tablet) are indicated for
the treatment of infections caused by
susceptible strains of the designated
organisms in the following conditions:
Lower respiratory tract infections,
caused by b-lactamase-producing strains
of Haemophilus influenzae and
Moraxella catarrhalis; otitis media,
caused by b-lactamase-producing strains
of H. influenzae and M. catarrhalis;
sinusitis, caused by b-lactamaseproducing strains of H. influenzae and
M. catarrhalis; skin and skin structure
infections, caused by b-lactamaseproducing strains of Staphylococcus
aureus, Escherichia coli, and Klebsiella
spp.; and urinary tract infections,
caused by b-lactamase-producing strains
of E. coli, Klebsiella spp., and
Enterobacter spp. AUGMENTIN ES–600
Powder for Suspension is indicated for
the treatment of pediatric patients with
recurrent or persistent acute otitis media
due to Streptococcus pneumoniae
(penicillin MICs ≤ 2 micrograms (mcg)/
mL), H. influenzae (including blactamase-producing strains), or M.
catarrhalis (including b-lactamaseproducing strains) characterized by the
following risk factors: antibiotic
exposure for acute otitis media within
the preceding 3 months, and either age
≤ 2 years or daycare attendance.
emcdonald on DSK2BSOYB1PROD with NOTICES
TABLE 1
Initial approval
date
Application No.
Drug
Applicant
NDA 50–597 ..................
AUGMENTIN ‘125’ (amoxicillin; clavulanate potassium) Chewable Tablet, 125 milligrams
(mg); Equivalent to (EQ) 31.25 mg base.
AUGMENTIN ‘250’ (amoxicillin; clavulanate potassium) Chewable Tablet, 250 mg; EQ 62.5
mg base.
GlaxoSmithKline, One Franklin Plaza, Philadelphia, PA 19101.
July 22, 1985.
Do ........................................................................
Do.
Do ..................................
VerDate Mar<15>2010
18:39 Dec 06, 2010
Jkt 223001
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
E:\FR\FM\07DEN1.SGM
07DEN1
76017
Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices
TABLE 1—Continued
Initial approval
date
Application No.
Drug
Applicant
NDA 50–725 ..................
AUGMENTIN ‘200’ (amoxicillin; clavulanate potassium) Powder for Oral Suspension, 200
mg/5 milliliters (mL); EQ 28.5 mg base/5 mL.
AUGMENTIN ‘400’ (amoxicillin; clavulanate potassium) Powder for Oral Suspension, 400
mg/5 mL; EQ 57 mg base/5 mL.
AUGMENTIN ‘200’ (amoxicillin; clavulanate potassium) Chewable Tablet, 200 mg; EQ 28.5
mg base.
AUGMENTIN ‘400’ (amoxicillin; clavulanate potassium) Chewable Tablet, 400 mg; EQ 57
mg base.
AUGMENTIN ES–600 (amoxicillin; clavulanate
potassium) Powder for Oral Suspension, 600
mg/5 mL; EQ 42.9 mg base/5 mL.
Do ........................................................................
May 31, 1996.
Do ........................................................................
Do.
Do ........................................................................
Do.
Do ........................................................................
Do.
SmithKline Beecham d/b/a GlaxoSmithKline,
One Franklin Plaza, Philadelphia, PA 19101.
June 22, 2001.
Do ..................................
NDA 50–726 ..................
Do ..................................
emcdonald on DSK2BSOYB1PROD with NOTICES
NDA 50–755 ..................
In a letter dated November 10, 2009,
GlaxoSmithKline notified FDA that the
AUGMENTIN (amoxicillin; clavulanate
potassium) products listed in this
document, among other drug products,
were being discontinued, and FDA
moved the drug products to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. Approved
ANDAs for the AUGMENTIN
(amoxicillin; clavulanate potassium)
products listed in this document are
listed in the Orange Book, and following
the discontinuation of the AUGMENTIN
(amoxicillin; clavulanate potassium)
products, ANDAs for certain of these
products were designated as the
reference listed drugs to which new
ANDAs should refer.
EAS Consulting Group, LLC,
submitted two citizen petitions dated
March 23, 2010 (FDA–2010–P–0172),
and March 26, 2010 (FDA–2010–P–
0177), under 21 CFR 10.30, requesting
that the Agency determine whether the
following products were withdrawn
from sale for reasons of safety or
effectiveness:
• AUGMENTIN ‘200’ (amoxicillin;
clavulanate potassium) Powder for Oral
Suspension, 200 mg/5 mL; EQ 28.5 mg
base/5 mL;
• AUGMENTIN ‘400’ (amoxicillin;
clavulanate potassium) Powder for Oral
Suspension, 400 mg/5 mL; EQ 57 mg
base/5 mL; and
• AUGMENTIN ES–600 (amoxicillin;
clavulanate potassium) Powder for Oral
Suspension, 600 mg/5 mL; EQ 42.9 mg
base/5 mL.
Although the citizen petitions did not
address the other AUGMENTIN
(amoxicillin; clavulanate potassium)
products listed in this document, those
products have also been discontinued.
On our own initiative, we have also
determined whether those products
VerDate Mar<15>2010
18:39 Dec 06, 2010
Jkt 223001
were withdrawn for safety or
effectiveness reasons.
After considering the citizen petitions
and reviewing Agency records, FDA has
determined under § 314.161 that the
AUGMENTIN (amoxicillin; clavulanate
potassium) products listed in this
document were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that the
AUGMENTIN (amoxicillin; clavulanate
potassium) products listed in this
document were withdrawn for reasons
of safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of the
AUGMENTIN (amoxicillin; clavulanate
potassium) products listed in this
document. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events and have found no information
that would indicate that these products
were withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list the AUGMENTIN
(amoxicillin; clavulanate potassium)
products listed in this document in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to the
AUGMENTIN (amoxicillin; clavulanate
potassium) products listed in this
document. Additional ANDAs that refer
to these products may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for these drug
products should be revised to meet
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: December 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30622 Filed 12–6–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–P–0275]
Determination That GLEEVEC (Imatinib
Mesylate) Capsules, 50 Milligrams and
100 Milligrams, Were Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that GLEEVEC (imatinib mesylate)
Capsules, 50 milligrams (mg) and 100
mg, were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for imatinib
mesylate capsules, 50 mg and 100 mg,
if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Rochelle Chodock Fink, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6236,
Silver Spring, MD 20993–0002, 301–
796–0838.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
SUMMARY:
E:\FR\FM\07DEN1.SGM
07DEN1
]]>Agencies
[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Pages 76016-76017]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30622]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2010-P-0172 and FDA-2010-P-0177]
Determination That AUGMENTIN `125' (Amoxicillin; Clavulanate
Potassium) Chewable Tablet and Six Other AUGMENTIN (Amoxicillin;
Clavulanate Potassium) Drug Products Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined that the
AUGMENTIN (amoxicillin; clavulanate potassium) drug products listed in
this notice were not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to these drug products, and it will allow FDA to
continue to approve ANDAs that refer to the products as long as they
meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Molly Flannery, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6237, Silver Spring, MD 20993-0002, 301-
796-3543.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162). Under Sec. 314.161(a)(1) (21 CFR 314.161(a)(1)), the
Agency must determine whether a listed drug was withdrawn from sale for
reasons of safety or effectiveness before an ANDA that refers to that
listed drug may be approved. FDA may not approve an ANDA that does not
refer to a listed drug. Under Sec. 314.161(a)(2), FDA must determine
whether a listed drug was withdrawn from sale for reasons of safety or
effectiveness whenever a listed drug is voluntarily withdrawn from sale
and ANDAs that refer to the listed drug have been approved. Section
314.161(d) provides that if FDA determines that a listed drug was
withdrawn from sale for reasons of safety or effectiveness, the Agency
will initiate proceedings that could result in the withdrawal of
approval of the ANDAs that refer to the listed drug.
The drug products listed in table 1 of this document are no longer
being marketed. Six of the products listed (AUGMENTIN `125' Chewable
Tablet, AUGMENTIN `250' Chewable Tablet, AUGMENTIN `200' Powder for
Suspension, AUGMENTIN `400' Powder for Suspension, AUGMENTIN `200'
Chewable Tablet, and AUGMENTIN `400' Chewable Tablet) are indicated for
the treatment of infections caused by susceptible strains of the
designated organisms in the following conditions: Lower respiratory
tract infections, caused by [beta]-lactamase-producing strains of
Haemophilus influenzae and Moraxella catarrhalis; otitis media, caused
by [beta]-lactamase-producing strains of H. influenzae and M.
catarrhalis; sinusitis, caused by [beta]-lactamase-producing strains of
H. influenzae and M. catarrhalis; skin and skin structure infections,
caused by [beta]-lactamase-producing strains of Staphylococcus aureus,
Escherichia coli, and Klebsiella spp.; and urinary tract infections,
caused by [beta]-lactamase-producing strains of E. coli, Klebsiella
spp., and Enterobacter spp. AUGMENTIN ES-600 Powder for Suspension is
indicated for the treatment of pediatric patients with recurrent or
persistent acute otitis media due to Streptococcus pneumoniae
(penicillin MICs <= 2 micrograms (mcg)/mL), H. influenzae (including
[beta]-lactamase-producing strains), or M. catarrhalis (including
[beta]-lactamase-producing strains) characterized by the following risk
factors: antibiotic exposure for acute otitis media within the
preceding 3 months, and either age <= 2 years or daycare attendance.
Table 1
----------------------------------------------------------------------------------------------------------------
Application No. Drug Applicant Initial approval date
----------------------------------------------------------------------------------------------------------------
NDA 50-597......................... AUGMENTIN `125' GlaxoSmithKline, One July 22, 1985.
(amoxicillin; Franklin Plaza,
clavulanate Philadelphia, PA
potassium) Chewable 19101.
Tablet, 125
milligrams (mg);
Equivalent to (EQ)
31.25 mg base.
Do................................. AUGMENTIN `250' Do.................... Do.
(amoxicillin;
clavulanate
potassium) Chewable
Tablet, 250 mg; EQ
62.5 mg base.
[[Page 76017]]
NDA 50-725......................... AUGMENTIN `200' Do.................... May 31, 1996.
(amoxicillin;
clavulanate
potassium) Powder for
Oral Suspension, 200
mg/5 milliliters
(mL); EQ 28.5 mg base/
5 mL.
Do................................. AUGMENTIN `400' Do.................... Do.
(amoxicillin;
clavulanate
potassium) Powder for
Oral Suspension, 400
mg/5 mL; EQ 57 mg
base/5 mL.
NDA 50-726......................... AUGMENTIN `200' Do.................... Do.
(amoxicillin;
clavulanate
potassium) Chewable
Tablet, 200 mg; EQ
28.5 mg base.
Do................................. AUGMENTIN `400' Do.................... Do.
(amoxicillin;
clavulanate
potassium) Chewable
Tablet, 400 mg; EQ 57
mg base.
NDA 50-755......................... AUGMENTIN ES-600 SmithKline Beecham d/b/ June 22, 2001.
(amoxicillin; a GlaxoSmithKline,
clavulanate One Franklin Plaza,
potassium) Powder for Philadelphia, PA
Oral Suspension, 600 19101.
mg/5 mL; EQ 42.9 mg
base/5 mL.
----------------------------------------------------------------------------------------------------------------
In a letter dated November 10, 2009, GlaxoSmithKline notified FDA
that the AUGMENTIN (amoxicillin; clavulanate potassium) products listed
in this document, among other drug products, were being discontinued,
and FDA moved the drug products to the ``Discontinued Drug Product
List'' section of the Orange Book. Approved ANDAs for the AUGMENTIN
(amoxicillin; clavulanate potassium) products listed in this document
are listed in the Orange Book, and following the discontinuation of the
AUGMENTIN (amoxicillin; clavulanate potassium) products, ANDAs for
certain of these products were designated as the reference listed drugs
to which new ANDAs should refer.
EAS Consulting Group, LLC, submitted two citizen petitions dated
March 23, 2010 (FDA-2010-P-0172), and March 26, 2010 (FDA-2010-P-0177),
under 21 CFR 10.30, requesting that the Agency determine whether the
following products were withdrawn from sale for reasons of safety or
effectiveness:
AUGMENTIN `200' (amoxicillin; clavulanate potassium)
Powder for Oral Suspension, 200 mg/5 mL; EQ 28.5 mg base/5 mL;
AUGMENTIN `400' (amoxicillin; clavulanate potassium)
Powder for Oral Suspension, 400 mg/5 mL; EQ 57 mg base/5 mL; and
AUGMENTIN ES-600 (amoxicillin; clavulanate potassium)
Powder for Oral Suspension, 600 mg/5 mL; EQ 42.9 mg base/5 mL.
Although the citizen petitions did not address the other AUGMENTIN
(amoxicillin; clavulanate potassium) products listed in this document,
those products have also been discontinued. On our own initiative, we
have also determined whether those products were withdrawn for safety
or effectiveness reasons.
After considering the citizen petitions and reviewing Agency
records, FDA has determined under Sec. 314.161 that the AUGMENTIN
(amoxicillin; clavulanate potassium) products listed in this document
were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
the AUGMENTIN (amoxicillin; clavulanate potassium) products listed in
this document were withdrawn for reasons of safety or effectiveness. We
have carefully reviewed our files for records concerning the withdrawal
of the AUGMENTIN (amoxicillin; clavulanate potassium) products listed
in this document. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events and have
found no information that would indicate that these products were
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the AUGMENTIN
(amoxicillin; clavulanate potassium) products listed in this document
in the ``Discontinued Drug Product List'' section of the Orange Book.
The ``Discontinued Drug Product List'' delineates, among other items,
drug products that have been discontinued from marketing for reasons
other than safety or effectiveness. FDA will not begin procedures to
withdraw approval of approved ANDAs that refer to the AUGMENTIN
(amoxicillin; clavulanate potassium) products listed in this document.
Additional ANDAs that refer to these products may also be approved by
the Agency as long as they meet all other legal and regulatory
requirements for the approval of ANDAs. If FDA determines that labeling
for these drug products should be revised to meet current standards,
the Agency will advise ANDA applicants to submit such labeling.
Dated: December 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30622 Filed 12-6-10; 8:45 am]
BILLING CODE 4160-01-P
