[Federal Register Volume 72, Number 22 (Friday, February 2, 2007)]
[Notices]
[Pages 5061-5062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1748]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006P-0052]


Determination That SUSTIVA (Efavirenz) 300-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Not Withdrawn From Sale for Reasons of Safety or Effectiveness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) has determined that 
SUSTIVA (efavirenz) 300-milligram (mg) tablets were not withdrawn from 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 (ANDAs) for 
efavirenz 300-mg tablets, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, 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 under a 
new drug application (NDA). Sponsors of ANDAs 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 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 Under FDA regulations, drugs are withdrawn from the list if the 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 
(Sec.  314.162 (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.
    In a citizen petition dated January 24, 2006 (Docket No. 2006P-
0052/CP1), submitted under 21 CFR 10.30, Robert W. Pollock of Lachman 
Consultant Services, Inc., requested that the agency determine whether 
SUSTIVA (efavirenz) 300-mg tablets were withdrawn from sale for reasons 
of safety or effectiveness. SUSTIVA (efavirenz) is approved for the 
treatment of human immunodeficiency virus (HIV) type 1 infections in 
combination with other antiretroviral agents. SUSTIVA (efavirenz) 300-
mg tablets are the subject of NDA 21-360 held by Bristol-Myers Squibb 
Pharma Company (BMS). FDA approved the NDA for SUSTIVA (efavirenz) 300-
mg tablets on February 1, 2002.
    After considering the citizen petition and reviewing agency 
records, FDA has determined that SUSTIVA (efavirenz)

[[Page 5062]]

300-mg tablets were not withdrawn from sale for reasons of safety or 
effectiveness. To date, BMS has never marketed SUSTIVA (efavirenz) 300-
mg tablets. In previous instances (see, e.g., 67 FR 79640, December 30, 
2002 (addressing a relisting request for Diazepam Autoinjector)), the 
agency has determined that, for purposes of Sec. Sec.  314.161 and 
314.162, never marketing an approved drug product is equivalent to 
withdrawing the drug from sale.
    The petitioner identified no data or other information suggesting 
that SUSTIVA (efavirenz) 300-mg tablets were withdrawn from sale as a 
result of safety or effectiveness concerns. FDA has reviewed its files 
for records concerning the withdrawal of SUSTIVA (efavirenz) 300-mg 
tablets. There is no indication that the decision not to market SUSTIVA 
(efavirenz) 300-mg tablets commercially is a function of safety or 
effectiveness concerns, and no information has been submitted to the 
docket concerning the reasons for which SUSTIVA (efavirenz) 300-mg 
tablets were withdrawn from sale. FDA's independent evaluation of 
relevant information has uncovered nothing that would indicate that 
SUSTIVA (efavirenz) 300-mg tablets were withdrawn from sale for reasons 
of safety or effectiveness.
    For the reasons outlined in this document, FDA has determined that 
SUSTIVA (efavirenz) 300-mg tablets were not withdrawn from sale for 
reasons of safety or effectiveness. Accordingly, the agency will 
continue to list SUSTIVA (efavirenz) 300-mg tablets 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 and effectiveness. ANDAs that refer to SUSTIVA (efavirenz) 
300-mg tablets may be approved by the agency, as long as they meet all 
relevant legal and regulatory requirements for approval of ANDAs.

    Dated: January 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-1748 Filed 2-1-07; 8:45 am]
BILLING CODE 4160-01-S