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###### Department of Health and Human Services

###### Food and Drug Administration 

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

# AGENCY:

Food and Drug Administration, HHS. 

# ACTION:

Notice.

# 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(FDA) has determined that KEFLEX (cephalexin) capsule, equivalent to (EQ) 333 milligrams (mg) base, was not withdrawn from sale for reasons of safety or effectiveness.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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved.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 §§ 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 § 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                           ( print 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