[Federal Register Volume 80, Number 3 (Tuesday, January 6, 2015)]
[Notices]
[Pages 509-510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30909]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-P-0980]
Determination That REYATAZ (Atazanavir Sulfate) Capsules, 100
Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or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 or Agency) has
determined that REYATAZ (atazanavir sulfate) capsules, 100 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(mg), were not withdrawn from sale for reasons of safety or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 atazanavir sulfate, 100 mg, if all
other legal and regulatory requirements are met.
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. 6224, 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drug was withdrawn from sale for reasons of safety or effectiveness (21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.
REYATAZ (atazanavir sulfate) capsules, 100 mg, is the subject of
NDA 21-567, held by Bristol-Myers Squibb, and initially approved on
June 20, 2003.
[[Page 510]]
REYATAZ is a protease inhibitor indicated for use in combination with
other antiretroviral agents for the treatment of human immunodeficiency
virus (HIV-1) infection in patients 3 months and older weighing at
least 10 kilograms.
In a letter dated August 19, 2014, Bristol-Myers Squibb notified
FDA that REYATAZ (atazanavir sulfate) capsules, 100 mg, had been
discontinued. The REYATAZ 150-, 200-, and 300-mg capsule strengths
continue to be marketed by Bristol-Myers Squibb. The 100-mg dosage
strength of this drug product is currently listed in the ``Discontinued
Drug Product List'' section of the Orange Book.
Lachman Consultant Services, Inc., submitted a citizen petition
dated July 7, 2014 (Docket No. FDA-2014-P-0980), under 21 CFR 10.30,
requesting that the Agency determine whether REYATAZ (atazanavir
sulfate) capsules, 100 mg, were 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 REYATAZ (atazanavir sulfate) capsules, 100 mg,
were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
REYATAZ (atazanavir sulfate) capsules, 100 mg, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of REYATAZ (atazanavir
sulfate) capsules, 100 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 REYATAZ (atazanavir
sulfate) capsules, 100 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 REYATAZ (atazanavir sulfate)
capsules, 100 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: December 30, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30909 Filed 1-5-15; 8:45 am]
BILLING CODE 4164-01-P