[Federal Register Volume 71, Number 28 (Friday, February 10, 2006)]
[Notices]
[Pages 7053-7054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1847]


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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Injection, 0.25 Milligrams per Milliliter, Was Not Withdrawn From Sale 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(mg) per milliliter (mL), was not withdrawn from sale for reasons of 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 Under FDA regulations, drugs are withdrawn from the list if the 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