Notice: Determination That PREZISTA (darunavir) Tablets, 300 Milligrams 
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Federal Register: Volume 77, Number 11 (Wednesday, January 18, 2012)
                  Page 2555

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) has determined that 
PREZISTA (darunavir) Tablets, 300 milligrams (mg), was not withdrawn 
from sale for reasons of safety or effectiveness. This determination 
will allow FDA to approve abbreviated new drug applications (ANDAs) for 
darunavir tablets, 300 mg, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Nam Kim, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, rm. 6320, Silver Spring, MD 20993-0002, (301) 796-3472.

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 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 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drug was withdrawn from sale for reasons of safety or effectiveness (21 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determine on its own initiative, whether a listed drug was withdrawn 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.
    PREZISTA (darunavir) Tablets, 300 mg, is the subject of NDA 21-976, 
held by Tibotec, Inc., and initially approved on June 23, 2006. 
PREZISTA is a human immunodeficiency virus (HIV-1) protease inhibitor 
indicated for the treatment of HIV-1 infection in adult patients. 
PREZISTA is also indicated for the treatment of HIV-1 infection in 
pediatric patients 6 years of age and older. PREZISTA must be 
coadministered with ritonavir (PREZISTA/ritonavir) and with other 
antiretroviral agents.
    PREZISTA (darunavir) Tablets, 300 mg, is currently listed in the 
``Discontinued Drug Product List'' section of the Orange Book.
    Lupin Pharmaceuticals, Inc. (Lupin), submitted a citizen petition 
dated October 14, 2011 (Docket No. FDA-2011-P-0756), under 21 CFR 
10.30, requesting that the Agency determine whether PREZISTA 
(darunavir) Tablets, 300 mg, was withdrawn from sale for reasons of 
safety or effectiveness. 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 PREZISTA (darunavir) 
Tablets, 300 mg, was not withdrawn for reasons of safety or 
effectiveness. The petitioner Lupin has identified no data or other 
information suggesting that PREZISTA (darunavir) Tablets, 300 mg, was 
withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of PREZISTA 
(darunavir) Tablets, 300 mg, from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events. We have found no information that would indicate that 
this product was withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list PREZISTA (darunavir) 
Tablets, 300 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 or effectiveness. ANDAs that 
refer to PREZISTA (darunavir) Tablets, 300 mg, 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: January 11, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-847 Filed 1-17-12; 8:45 am]
BILLING CODE 4160-01-P