[Federal Register Volume 67, Number 128 (Wednesday, July 3, 2002)]
[Notices]
[Pages 44611-44612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16668]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02P-0043]


Determination That Piperacillan for Injection USP, 40-Gram 
Pharmacy Bulk Package, Was Not Withdrawn From Sale for Reasons of 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 
piperacillan for injection USP (PIPRACIL), 40-gram (g) pharmacy bulk 
package, was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for piperacillan for injection USP, 40-g 
pharmacy bulk package.

FOR FURTHER INFORMATION CONTACT: Nicole Mueller, 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 Under FDA regulations, drugs are withdrawn from the list if the 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).
    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.
    Piperacillan for injection USP, 40-g pharmacy bulk package, is the 
subject of approved NDA 50-545 held by Lederle (part of Wyeth-Ayerst 
Pharmaceuticals) under the trade name PIPRACIL. Piperacillan for 
injection USP, 40-g pharmacy bulk package, is a broad-spectrum 
penicillin indicated for the treatment of serious infections and for 
prophylactic use in surgery. According to information from Wyeth-Ayerst 
submitted in 2001, production of the 40-g pharmacy bulk package was 
discontinued. On January 17, 2002, Mr. Michael Lisjak submitted a 
citizen petition (Docket No. 02P-0043) under 21 CFR 10.30 and 314.122, 
requesting that the agency determine whether piperacillan for injection 
USP, 40-g pharmacy bulk package, was withdrawn from sale for reasons of 
safety or effectiveness. The petitioner seeks this determination in 
preparation for filing an ANDA for piperacillan for injection USP, 40-g 
pharmacy bulk package.
    The agency has determined that Wyeth-Ayerst's piperacillan for 
injection USP, 40-g pharmacy bulk package, was not withdrawn from sale 
for reasons of safety or effectiveness. Two grounds support the 
agency's finding. First, Wyeth-Ayerst continues to market PIPRACIL in 
2-, 3-, and 4-g vials. The 40-g pharmacy bulk package is a larger 
package of the same product; it contains up to 20 doses of piperacillan 
for injection USP. Second, the petitioner identified no data or other 
information suggesting that PIPRACIL (piperacillan for injection USP, 
40-g pharmacy bulk package) was withdrawn

[[Page 44612]]

from sale as a result of safety or effectiveness concerns. FDA has 
independently evaluated relevant literature and data for possible 
postmarketing adverse event reports, but has found no information that 
would indicate this product was withdrawn for reasons of safety or 
effectiveness.
    After considering the citizen petition and reviewing its records, 
FDA determines that, for the reasons outlined previously, Wyeth-
Ayerst's piperacillan for injection USP, 40-g pharmacy bulk package, 
was not withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the agency will continue to list piperacillan for 
injection USP, 40-g pharmacy bulk package, 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 discontinued from marketing for reasons other than safety or 
effectiveness. ANDAs that refer to piperacillan for injection USP, 40-g 
pharmacy bulk package, may be approved by the agency.

    Dated: June 24, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-16668 Filed 7-2-02; 8:45 am]
BILLING CODE 4160-01-S