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Sec. 393.200 because it is obsolete.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Withdrawn From Sale for Reasons of 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. 

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listed in this notice were not withdrawn 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 § 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. 

TABLE 1 

Application No. Drug Applicant Initial approval 

date 

NDA 50–597 .................. AUGMENTIN ‘125’ (amoxicillin; clavulanate potassium) Chewable Tablet, 125 milligrams 

(mg); Equivalent to (EQ) 31.25 mg base.

GlaxoSmithKline, One Franklin Plaza, Philadelphia, PA 19101.July 22, 1985. 

Do .................................. AUGMENTIN ‘250’ (amoxicillin; clavulanate potassium) Chewable Tablet, 250 mg; EQ 62.5 

mg base.

Do ........................................................................ Do. 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices 76017 

TABLE 1—Continued 

Application No. Drug Applicant Initial approval 

date 

NDA 50–725 .................. AUGMENTIN ‘200’ (amoxicillin; clavulanate potassium) Powder for Oral Suspension, 200 

mg/5 milliliters (mL); EQ 28.5 mg base/5 mL.

Do ........................................................................ May 31, 1996. 

Do .................................. AUGMENTIN ‘400’ (amoxicillin; clavulanate potassium) Powder for Oral Suspension, 400 

mg/5 mL; EQ 57 mg base/5 mL.

Do ........................................................................ Do. 

NDA 50–726 .................. AUGMENTIN ‘200’ (amoxicillin; clavulanate potassium) Chewable Tablet, 200 mg; EQ 28.5 

mg base.

Do ........................................................................ Do. 

Do .................................. AUGMENTIN ‘400’ (amoxicillin; clavulanate potassium) Chewable Tablet, 400 mg; EQ 57 

mg base.

Do ........................................................................ Do. 

NDA 50–755 .................. AUGMENTIN ES–600 (amoxicillin; clavulanate 

potassium) Powder for Oral Suspension, 600 

mg/5 mL; EQ 42.9 mg base/5 mL.

SmithKline Beecham d/b/a GlaxoSmithKline, 

One Franklin Plaza, Philadelphia, PA 19101.

June 22, 2001. 

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 § 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 

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. 

SUMMARY: 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 


emcdonald on DSK2BSOYB1PROD with NOTICES