[Federal Register: February 3, 2006 (Volume 71, Number 23)]
[Notices]
[Page 5858-5859]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03fe06-73]
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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per Milliliter (200 Milligrams), Was Not Withdrawn From Sale for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(200 mg), was not withdrawn from sale for reasons of safety or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 Under FDA regulations, drugs are withdrawn from the list if the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