[Federal Register Volume 76, Number 70 (Tuesday, April 12, 2011)]
[Notices]
[Pages 20357-20358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-P-0256]


Determination That KEFLEX (Cephalexin) Capsule, Equivalent to 333 
Milligrams Base, Was Not Withdrawn From Sale for Reasons of Safety or 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 
KEFLEX (cephalexin) capsule, equivalent to (EQ) 333 milligrams (mg) 
base, was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for cephalexin capsule, EQ 333 mg base, 
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:  Patrick Raulerson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6368, Silver Spring, MD 20993-0002, 301-
796-3522.

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.
    KEFLEX (cephalexin) capsule, EQ 333 mg base, is the subject of NDA 
050405 held by Victory Pharma, Inc., and the 333-mg strength was 
approved on May 12, 2006. KEFLEX is a cephalosporin antibiotic 
indicated for the treatment of respiratory tract infections caused by 
Streptococcus pneumoniae and S. pyogenes, as well as certain other 
infections caused by susceptible strains of certain designated micro-
organisms as described in the product labeling.
    KEFLEX (cephalexin) capsule, EQ 333 mg base, has never been 
marketed. In previous instances (see 72 FR 9763, March 5, 2007; 61 FR 
25497, May 21, 1996), the Agency has determined that, for purposes of 
Sec. Sec.  314.161 and 314.162, never marketing an approved drug 
product is equivalent to withdrawing the drug from sale.
    Lachman Consultant Services, Inc., submitted a citizen petition 
dated May 29, 2009 (Docket No. FDA-2009-P-0256), under 21 CFR 10.30, 
requesting that the Agency determine whether KEFLEX (cephalexin) 
capsule, EQ 333 mg base, was withdrawn from sale for reasons of safety 
or effectiveness. After considering the citizen petition and reviewing 
Agency records, FDA has determined under Sec.  314.161 that KEFLEX 
(cephalexin) capsule, EQ 333 mg base, was not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that KEFLEX (cephalexin) capsule, EQ 333 mg 
base, was withdrawn for reasons of safety or effectiveness. We have 
carefully reviewed our files for records concerning the withdrawal of 
KEFLEX (cephalexin) capsule, EQ 333 mg base, from sale. We have also 
independently evaluated relevant literature and data for possible 
postmarketing adverse events. We have found no information

[[Page 20358]]

that would indicate that this product was withdrawn from sale for 
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list KEFLEX (cephalexin) 
capsule, EQ 333 mg base, 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. ANDAs that refer to KEFLEX (cephalexin) capsule, EQ 333 
mg base, may 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 this drug product should be revised to 
meet current standards, the Agency will advise ANDA applicants to 
submit such labeling.

    Dated: April 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8617 Filed 4-11-11; 8:45 am]
BILLING CODE 4160-01-P