14118 Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices 

Dated: March 20, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5470 Filed 3–23–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006P–0255] 

Determination That DURICEF 

(Cefadroxil USP) Tablets, 1 Gram, and 

Capsules, 500 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Withdrawn From Sale for Reasons of 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 DURICEF (cefadroxil USP) Tablets, 

1 gram (g), and Capsules, 500 milligrams 

(mg), were not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

continue to approve abbreviated new 

drug applications (ANDAs) for 

cefadroxil USP tablets, 1 g, and 

cefadroxil USP capsules, 500 mg. 

FOR FURTHER INFORMATION CONTACT: 

Mary Catchings, Center for Drug 

Evaluation and Research (HFD–7), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–594–

2041. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) (the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

sponsors 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 typically a version of the drug 

that was previously approved. Sponsors 

of ANDAs 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 Cosmetics 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 generally known as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are withdrawn from the list if the 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 21 CFR 314.161(a), the 

circumstances under which the agency 

must determine whether a listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness include: (1) 

Before an ANDA that refers to that listed 

drug may be approved and (2) 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 safety or 

effectiveness reasons, the agency will 

initiate proceedings that could result in 

the withdrawal of approval of the 

ANDAs that refer to the listed drug. 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

DURICEF (cefadroxil USP) Tablets, 1 

g, and Capsules, 500 mg, are the subjects 

of approved NDA 50–528 and NDA 50–

512, respectively, held by Warner 

Chilcott, Inc. (Warner Chilcott). 

DURICEF is an antibiotic indicated to 

treat infections of the urinary tract, skin, 

throat, and tonsils, caused by specific 

bacteria, including streptococci, 

staphylococci, and Escherichia coli. 

Warner Chilcott has informed FDA that 

DURICEF (cefadroxil USP) Tablets 1 g, 

and Capsules, 500 mg, have been 

withdrawn from sale. 

In a citizen petition dated June 13, 

2006 (Docket No. 2006P–0255/CP1), 

submitted under 21 CFR 10.30, Orchid 

Healthcare (a division of Orchid 

Chemicals & Pharmaceuticals Ltd.) 

requested that the agency determine 

whether DURICEF (cefadroxil USP) 

Tablets, 1 g, were withdrawn from sale 

for reasons of safety or effectiveness. In 

addition, there are approved ANDAs 

that refer to DURICEF (cefadroxil USP) 

Tablets, 1 g, and Capsules, 500 mg. 

The agency has determined that 

Warner Chilcott’s DURICEF (cefadroxil 

USP) Tablets, 1 g, and Capsules, 500 mg, 

were not withdrawn from sale for 

reasons of safety or effectiveness. The 

petitioner identified no data or other 

information suggesting that DURICEF 

Tablets, 1 g, and Capsules, 500 mg, were 

withdrawn from sale for reasons of 

safety or effectiveness. FDA has 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events and has 

found no information that would 

indicate that either DURICEF Tablets, 1 

g, or Capsules, 500 mg, were withdrawn 

from sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing agency records, FDA 

determines that, for the reasons outlined 

in this document, DURICEF (cefadroxil 

USP) Tablets, 1 g, and Capsules, 500 mg, 

were not withdrawn from sale for 

reasons of safety or effectiveness. 

Accordingly, the agency will continue 

to list DURICEF (cefadroxil USP) 

Tablets, 1 g, and Capsules, 500 mg, 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. Approved 

ANDAs that refer to DURICEF cefadroxil 

USP) Tablets, 1 g, and Capsules, 500 mg, 

are unaffected by the withdrawal of 

these products from sale. ANDAs that 

refer to cefadroxil USP (tablets, 1 g, and 

cefadroxil USP capsules, 500 mg, may 

be approved by the agency as long as 

they meet all relevant legal and 

regulatory requirements for the approval 

of ANDAs. 

Dated: March 15, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5415 Filed 3–23–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006E–0240] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; REVLIMID 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

REVLIMID and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that human drug product. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 


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