[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Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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not withdrawn from sale for reasons of safety or effectiveness.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drug was withdrawn from sale for reasons of safety or effectiveness (21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]
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