[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Pages 76016-76017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30622]


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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Clavulanate Potassium) Drug Products Were Not Withdrawn From Sale for 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.

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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this notice were not withdrawn from sale for reasons of safety or 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
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          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:
    <bullet> AUGMENTIN `200' (amoxicillin; clavulanate potassium) 
Powder for Oral Suspension, 200 mg/5 mL; EQ 28.5 mg base/5 mL;
    <bullet> AUGMENTIN `400' (amoxicillin; clavulanate potassium) 
Powder for Oral Suspension, 400 mg/5 mL; EQ 57 mg base/5 mL; and
    <bullet> 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