[Federal Register Volume 71, Number 23 (Friday, February 3, 2006)]
[Notices]
[Pages 5858-5859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1475]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005P-0023]


Determination That TEQUIN (Gatifloxacin) Injection, 10 Milligrams 
per Milliliter (200 Milligrams), Was Not Withdrawn From Sale for 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 
TEQUIN (gatifloxacin) injection, 10 milligrams (mg) per milliliter (mL) 
(200 mg), was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for gatifloxacin injection, 10 mg/mL (200 
mg).

FOR FURTHER INFORMATION CONTACT: Elaine Tseng, 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 (the 1984 
amendments) (Pub. L. 98-417), 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

[[Page 5859]]

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 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 Under FDA regulations, drugs are withdrawn from the list if the 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)(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.
    TEQUIN (gatifloxacin) injection, 10 mg/mL (200 mg), is the subject 
of approved NDA 21-062 held by Bristol-Myers Squibb. TEQUIN 
(gatifloxacin) injection, 10 mg/mL (200 mg), is an antibiotic used to 
treat adults with lung, sinus, or urinary tract infections.
    FDA approved the NDA for TEQUIN (gatifloxacin) injection, 10 mg/mL 
(200 mg) and 10 mg/mL (400 mg), on December 17, 1999. On January 27, 
2003, FDA received revised product labeling relating to several 
approved supplements for TEQUIN (gatifloxacin). This revised labeling 
deleted references to TEQUIN (gatifloxacin) injection, 10 mg/mL (200 
mg), indicating that this product was no longer being marketed. 
Therefore, it was moved from the prescription drug product list to 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.
    Apotex Corp., submitted a citizen petition dated January 13, 2005 
(Docket No. 2005P-0023/CP1), under 21 CFR 10.30, requesting that the 
agency determine whether TEQUIN (gatifloxacin) injection, 10 mg/mL (200 
mg), was withdrawn from sale for reasons of safety or effectiveness. 
After considering the citizen petition and reviewing agency records, 
FDA has determined that TEQUIN (gatifloxacin) injection, 10 mg/mL (200 
mg), approved under NDA 21-062, was not withdrawn from sale for reasons 
of safety or effectiveness. The petitioner identified no data or other 
information suggesting that TEQUIN (gatifloxacin) injection, 10 mg/mL 
(200 mg), was withdrawn from sale as a result of safety or 
effectiveness concerns. FDA's independent evaluation of relevant 
literature and data has not uncovered anything that would indicate that 
this product was withdrawn for reasons of safety or effectiveness. 
Accordingly, the agency will continue to list TEQUIN (gatifloxacin) 
injection, 10 mg/mL (200 mg), in the ``Discontinued Drug Product List'' 
section of the Orange Book. ANDAs that refer to TEQUIN (gatifloxacin) 
injection, 10 mg/mL (200 mg), may be approved by the agency.

    Dated: January 27, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1475 Filed 2-2-06; 8:45 am]
BILLING CODE 4160-01-S