[Federal Register Volume 79, Number 70 (Friday, April 11, 2014)]
[Notices]
[Pages 20214-20215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-08148]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-1515]
Determination That ZOVIRAX (Acyclovir Sodium) Injection,
Equivalent to 250 Milligrams Base/Vial, 500 Milligrams Base/Vial, and 1
Gram Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or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
ZOVIRAX (acyclovir sodium) Injection, equivalent to (EQ) 250 milligrams
(mg) base/vial, 500 mg base/vial, and 1gram (g) base/vial, was not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for ZOVIRAX (acyclovir sodium) Injection, EQ 250
mg base/vial, 500 mg base/vial, and 1 g base/vial, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Darren Eicken, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-
402-0978.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
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 a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
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 known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed 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).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
ZOVIRAX (acyclovir sodium) Injection, EQ 250 mg base/vial, 500 mg
base/vial, and 1g base/vial, is the subject of NDA 18-603, held by
GlaxoSmithKline and initially approved on October 22, 1982. ZOVIRAX
(acyclovir sodium) is indicated for the treatment of herpes and
varicella-zoster (shingles) in immunocompromised patients.
In a letter dated June 20, 2005, GlaxoSmithKline notified FDA that
ZOVIRAX (acyclovir sodium) Injection, EQ 250 mg base/vial, 500 mg base/
vial, and 1g base/vial, was being discontinued, and FDA moved the drug
product to the ``Discontinued Drug Product List'' section of the Orange
Book.
Lachman Consultant Services, Inc., submitted a citizen petition
dated November 15, 2013 (Docket No. FDA-2013-P-1515), under 21 CFR
10.30, requesting that the Agency determine whether ZOVIRAX (acyclovir
sodium) Injection, EQ 1 g base/vial, was withdrawn from sale for
reasons of safety or effectiveness. Although the citizen petition did
not address the 250 mg and 500 mg strengths, those strengths have also
been discontinued. On our own initiative, we have also determined
whether those strengths were withdrawn for safety or effectiveness
reasons.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that ZOVIRAX (acyclovir sodium) Injection, EQ 250
mg base/vial, 500 mg base/vial, and 1g base/vial, was
[[Page 20215]]
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that ZOVIRAX
(acyclovir sodium) Injection, EQ 250 mg base/vial, 500 mg base/vial,
and 1 g base/vial, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of ZOVIRAX (acyclovir sodium) Injection, EQ
250 mg base/vial, 500 mg base/vial, and 1g base/vial, from sale. We
have also independently evaluated relevant literature and data for
possible postmarketing adverse events. We have reviewed the available
evidence and determined that these products were not withdrawn from
sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list ZOVIRAX (acyclovir
sodium) Injection, EQ 250 mg base/vial, 500 mg base/vial, and 1g base/
vial, 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 ZOVIRAX
(acyclovir sodium) Injection, EQ 250 mg base/vial, 500 mg base/vial,
and 1g base/vial, may be approved by the Agency as long as they meet
all other legal and regulatory requirements for the approval of ANDAs.
If FDA determines that labeling for this drug product should be revised
to meet current standards, the Agency will advise ANDA applicants to
submit such labeling.
Dated: April 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08148 Filed 4-10-14; 8:45 am]
BILLING CODE 4160-01-P