[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18558-18559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07337]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-1379]


Determination That PREZISTA (Darunavir) Tablets, 400 Milligrams, 
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 or the Agency) has 
determined that PREZISTA (darunavir) tablets, 400 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not withdrawn from sale for reasons of safety or effectiveness.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, 400 mg, if all other legal 
and regulatory requirements are met.

[[Page 18559]]


FOR FURTHER INFORMATION CONTACT: Na'Im R. Moses, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 240-
402-3990.

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drug was withdrawn from sale for reasons of safety or effectiveness (21 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.
    PREZISTA (darunavir) tablets, 400 mg, is the subject of NDA 21-976, 
held by Janssen Products, LP, 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. It is 
also indicated for the treatment of HIV-1 infection in pediatric 
patients 3 years of age and older. PREZISTA must be coadministered with 
ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents.
    In an email dated July 30, 2013, Janssen Products, LP, notified FDA 
that PREZISTA (darunavir) tablets, 400 mg, was being discontinued for 
the U.S. market only. The PREZISTA 800-mg tablet continues to be 
marketed in the United States. Lachman Consultant Services, Inc., 
submitted a citizen petition dated October 21, 2013 (Docket No. FDA-
2013-P-1379), under 21 CFR 10.30, requesting that the Agency determine 
whether PREZISTA (darunavir) tablets, 400 mg, was withdrawn from sale 
for reasons of safety or effectiveness. In January 2014, FDA moved the 
400-mg dosage strength of this drug product to the ``Discontinued Drug 
Product List'' section of the Orange Book.
    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, 400 mg, was not 
withdrawn for reasons of safety or effectiveness. The petitioner has 
identified no data or other information suggesting that PREZISTA 
(darunavir) tablets, 400 mg, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of PREZISTA (darunavir) tablets, 400 mg, 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 the product was not withdrawn 
from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list PREZISTA (darunavir) 
tablets, 400 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, 400 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: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07337 Filed 4-1-14; 8:45 am]
BILLING CODE 4160-01-P