[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Notices]
[Pages 80775-80776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32496]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-P-1898]


Determination That KYTRIL (Granisetron Hydrochloride) Tablets, 
Equivalent 1 Milligram and 2 Milligram Base, Were Not Withdrawn From 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 KYTRIL (granisetron hydrochloride) tablets, equivalent 
(EQ) 1 milligram (mg) and 2 mg base, were not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve abbreviated new drug applications (ANDAs) for KYTRIL 
(granisetron hydrochloride) tablets, EQ 1 mg and 2 mg base, if all 
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6246, Silver Spring, MD 20993-0002, 240-402-0979.

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

[[Page 80776]]

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.
    KYTRIL (granisetron hydrochloride) tablets, EQ 1 mg and 2 mg base, 
are the subject of NDA 020305, held by Hoffmann-La Roche, Inc., and 
initially approved on March 16, 1995. KYTRIL is indicated for the 
prevention of nausea and/or vomiting associated with initial and repeat 
courses of emetogenic cancer therapy, including high-dose cisplatin, 
and for the prevention and treatment of postoperative nausea and 
vomiting in adults.
    On April 30, 2012, Hoffman-La Roche notified FDA that KYTRIL 
(granisteron hydrochloride) tablets, EQ 1 mg and 2 mg base, were being 
discontinued, and FDA moved the drug products to the ``Discontinued 
Drug Product List'' section of the Orange Book.
    Kurt R. Karst, on behalf of Hyman, Phelps & McNamara, P.C., 
submitted a citizen petition dated May 27, 2015 (Docket No. FDA-2015-P-
1898), under 21 CFR 10.30, requesting that the Agency determine whether 
KYTRIL (granisteron hydrochloride) tablets, EQ 1 mg and 2 mg base, 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 KYTRIL (granisteron hydrochloride) tablets, EQ 
1 mg and 2 mg base, were not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that KYTRIL (granisteron hydrochloride) tablets, 
EQ 1 mg and 2 mg base, were withdrawn for reasons of safety or 
effectiveness We have carefully reviewed our files for records 
concerning the withdrawal of KYTRIL (granisteron hydrochloride) 
tablets, EQ 1 mg and 2 mg base, 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 products were not withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list KYTRIL (granisteron 
hydrochloride) tablets, EQ 1 mg and 2 mg base, 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 KYTRIL (granisteron hydrochloride) 
tablets, EQ 1 mg and 2 mg base, 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 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32496 Filed 12-24-15; 8:45 am]
 BILLING CODE 4164-01-P