[Federal Register: February 10, 2006 (Volume 71, Number 28)]
[Notices]
[Page 7053-7054]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10fe06-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005P-0104]
Determination That PEPTAVLON (Pentagastrin) for Subcutaneous
Injection, 0.25 Milligrams per Milliliter, Was Not Withdrawn From Sale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
PEPTAVLON (pentagastrin) for subcutaneous injection, 0.25 milligrams
(mg) per milliliter (mL), was not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for pentagastrin for
subcutaneous injection, 0.25 mg/mL.
FOR FURTHER INFORMATION CONTACT: Tawni B. Schwemer, 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 (Public Law 98-417)
(the 1984 amendments), 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
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 Under FDA regulations, drugs are withdrawn from the list if the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).
PEPTAVLON for subcutaneous injection is the subject of approved NDA
17-048 held by Wyeth Ayerst Laboratories (Wyeth Ayerst). PEPTAVLON
(pentagastrin) for subcutaneous injection is a testing agent to help
diagnose problems or diseases of the stomach. This test determines how
much acid a patient's stomach produces.
PEPTAVLON for subcutaneous injection, 0.25 mg/mL, was approved on
July 26, 1974. Wyeth Ayerst ceased manufacture of PEPTAVLON for
subcutaneous injection, 0.25 mg/mL, in March 2002, and requested that
FDA withdraw approval of the NDA (68 FR 49481, August 18, 2003).
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.
Under 21 CFR 314.161(a)(3), the agency must determine whether a
listed drug was withdrawn from sale for reasons of safety or
effectiveness when a person petitions for such a determination under 21
CFR 10.25(a) and Sec. 10.30 (21 CFR 10.30).
Arnall Golden Gregory LLP submitted a citizen petition dated March
7, 2005 (Docket No. 2005P-0104/CP1), under Sec. 10.30, requesting that
the agency determine whether PEPTAVLON (pentagastrin) for subcutaneous
injection, 0.25 mg/mL, was withdrawn from sale for reasons of safety or
effectiveness. After considering the citizen petition and reviewing
agency records, FDA has determined that PEPTAVLON for subcutaneous
injection, 0.25 mg/mL, approved under NDA 17-048, was not withdrawn
from sale for reasons of safety or effectiveness. The petitioner
identified
[[Page 7054]]
no data or other information suggesting that PEPTAVLON (pentagastrin)
for subcutaneous injection, 0.25 mg/mL, 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
PEPTAVLON (pentagastrin) for subcutaneous injection, 0.25 mg/mL, in the
``Discontinued Drug Product List'' section of the Orange Book. ANDAs
that refer to PEPTAVLON for subcutaneous injection, 0.25 mg/mL, may be
approved by the agency.
Dated: February 2, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1847 Filed 2-9-06; 8:45 am]
BILLING CODE 4160-01-S