[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Milligrams Base, Was Not Withdrawn From Sale for Reasons of Safety or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base, was not withdrawn from sale for reasons of safety or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