[Federal Register Volume 63, Number 152 (Friday, August 7, 1998)]
[Notices]
[Pages 42406-42407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21129]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98P-0220]


Determination That Acyclovir 200-Milligram Tablets Were 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Withdrawn From Sale for Reasons of Safety or Effectiveness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) is announcing its 
determination that acyclovir 200-milligram (mg) tablets were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDA's) for acyclovir 200-mg tablets.

FOR FURTHER INFORMATION CONTACT: Richard L. Schwartzbard, 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 (Pub. L. 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 a 
version of the drug that was previously approved under a new drug 
application (NDA). Sponsors of ANDA's do not have to repeat the 
extensive clinical testing otherwise necessary to gain approval of an 
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 included what is now section 505(j)(6) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(6)), 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,'' a publication generally known as the 
``Orange Book.'' Under the FDA regulations, drugs are withdrawn from 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). Regulations also provide that the 
agency must make a determination as to 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 
(Sec. 314.161(a)(1) (21 CFR 314.161(a)(1)). FDA may not approve an ANDA 
that does not refer to a listed drug.
    In a citizen petition dated September 17, 1997 (Docket No. 98P-
0220/CP1), received by FDA on April 1, 1998, and submitted in 
accordance with 21 CFR 314.122, TorPharm Inc., requested that the 
agency determine whether acyclovir 200-mg tablets were withdrawn from 
sale for reasons of safety or effectiveness. Acyclovir 200-mg tablets 
are the subject of approved ANDA 74-

[[Page 42407]]

556 held by Novopharm Ltd.\1\ FDA approved ANDA 74-556 on April 22, 
1997, and subsequently declared that Novopharm's acyclovir 200-mg 
tablets are a reference listed drug. However, after learning that 
Novopharm decided not to market ANDA 74-556, FDA moved the listing for 
acyclovir 200-mg tablets to the ``Discontinued Drug Product List'' 
section of the Orange Book.
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    \1\ The reference listed drug upon which ANDA 74-556 itself was 
approved was Zovirax (acyclovir) 200-mg capsules.
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    FDA has reviewed its records and, under Sec. 314.161, has 
determined that Novopharm's decision not to market its approved ANDA 
for acyclovir 200-mg tablets was not for reasons of safety or 
effectiveness. Accordingly, the agency will maintain acyclovir 200-mg 
tablets in the ``Discontinued Drug Product List'' section of the Orange 
Book. The ``Discontinued Drug Product List'' identifies, among other 
items, drug products that have been discontinued from marketing for 
reasons other than safety or effectiveness. ANDA's that refer to 
acyclovir 200-mg tablets may be approved by the agency.

    Dated: July 31, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-21129 Filed 8-6-98; 8:45 am]
BILLING CODE 4160-01-F