[Federal Register Volume 72, Number 94 (Wednesday, May 16, 2007)]
[Notices]
[Page 27575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9348]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006P-0372]


Determination That MEPRON (Atovaquone) Tablets, 250 milligrams, 
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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) has determined that 
MEPRON (atovaquone) tablets, 250 milligrams (mg), were not withdrawn 
from sale for reasons of safety or effectiveness. This determination 
will allow FDA to approve abbreviated new drug applications (ANDAs) for 
atovaquone tablets, 250 mg.

FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, 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 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 (the 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 Under FDA regulations, drugs are withdrawn from the 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the listed drug was withdrawn from sale for reasons of safety or 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 (Sec.  314.161(a)(1) (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.
    MEPRON (atovaquone) tablets, 250 mg, are the subject of approved 
NDA 20-259 held by GlaxoSmithKline (Glaxo). MEPRON (atovaquone) 
tablets, 250 mg, approved November 25, 1992, are indicated for the 
prevention of Pneumocystis carinii pneumonia in patients who are 
intolerant to trimethoprim-sulfamethoxazole (TMP-SMX). Glaxo ceased 
marketing MEPRON (atovaquone) tablets, 250 mg, in 1995.
    Lachman Consultant Services, Inc., submitted a citizen petition 
dated September 7, 2006 (Docket No. 2006P-0372/CP1), under 21 CFR 
10.30, requesting that the agency determine, as described in Sec.  
314.161, whether MEPRON (atovaquone) tablets, 250 mg, were withdrawn 
from sale for reasons of safety or effectiveness.The agency has 
determined that Glaxo's MEPRON (atovaquone) tablets, 250 mg, were not 
withdrawn from sale for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
MEPRON tablets, 250 mg, were withdrawn from sale as a result of safety 
or effectiveness concerns. FDA has independently evaluated relevant 
literature and data for adverse event reports and 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 in this notice, Glaxo's 
MEPRON (atovaquone) tablets, 250 mg, were not withdrawn from sale for 
reasons of safety or effectiveness. Accordingly, the agency will list 
MEPRON (atovaquone) tablets, 250 mg, 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 
oreffectiveness. ANDAs that refer to MEPRON (atovaquone) tablets, 250 
mg, may be approved by the agency as long as they meet all relevant 
legal and regulatory requirements for the approval of ANDAs.

    Dated: May 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9348 Filed 5-15-07; 8:45 am]
BILLING CODE 4160-01-S