[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Pages 14023-14024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5947]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-P-0177]


Determination that ROCEPHIN (Ceftriaxone Sodium) Injection, 250 
Milligrams, 500 Milligrams, 1 Gram, 2 Grams, and 10 Grams Base/Vial, 
Approved Under New Drug Application 050585, Were Not Withdrawn From 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 ROCEPHIN 
(ceftriaxone sodium) Injection, 250 milligrams (mg), 500mg, 1 gram (g), 
2g, and 10g base/vial, approved under new drug application (NDA) 
050585, were not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for any of these products 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 an 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.
    ROCEPHIN (ceftriaxone sodium) Injection, 250mg, 500mg, 1g, 2g, and 
10g base/vial, are the subject of NDA 050585 held by F. Hoffman-La 
Roche Ltd. (La Roche). ROCEPHIN (ceftriaxone sodium) is a semisynthetic 
cephalosporin antibiotic for intravenous or intramuscular 
administration and is indicated for the treatment of certain infections 
as described in the labeling. The drug products approved under NDA 
050585 are currently listed in the ``Discontinued Drug Product List'' 
section of the Orange Book.
    Steven H. Sklar of Leydig, Voit & Mayer, Ltd., submitted a citizen 
petition dated April 3, 2009 (Docket No. FDA-2009-P-0177), under 21 CFR 
10.30, requesting that FDA determine that ROCEPHIN (ceftriaxone sodium) 
Injection, 250mg, 500mg, 1g, 2g, and 10g base/vial, approved under NDA 
050585, were withdrawn from sale for reasons other than safety or 
effectiveness.
    After considering the citizen petition and reviewing Agency 
records, FDA has determined under Sec.  314.161 that ROCEPHIN 
(ceftriaxone sodium) Injection, 250mg, 500mg, 1g, 2g, and 10g base/
vial, approved under NDA 050585, were not withdrawn from sale for 
reasons of safety or effectiveness. The petitioner has identified no 
data or other information suggesting that these products were withdrawn 
from sale for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of these 
products from sale. We have also independently evaluated the relevant 
literature and data for possible postmarketing adverse events. We have 
found no information that would indicate that any of these products 
were

[[Page 14024]]

withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list ROCEPHIN (ceftriaxone 
sodium) Injection, 250mg, 500mg, 1g, 2g, and 10g base/vial, approved 
under NDA 050585, 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 withdrawn from sale for 
reasons other than safety or effectiveness. ANDAs that refer to any of 
the products described in this notice may be approved by FDA as long as 
they meet all other legal and regulatory requirements for the approval 
of ANDAs. If FDA determines that labeling for any of these drug 
products should be revised to meet current standards, the Agency will 
advise ANDA applicants to submit such labeling.

    Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5947 Filed 3-14-11; 8:45 am]
BILLING CODE 4160-01-P