Determination That KYTRIL (Granisetron Hydrochloride) Tablets, Equivalent 1 Milligram and 2 Milligram Base, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 80775-80776 [2015-32496]
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Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human biological product and
continues until FDA grants permission
to market the biological product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human biological product will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human biologic product KADCYLA
(ado-trastuzumab emtansine).
KADCYLA is indicated as a single agent,
for the treatment of patients with HER2positive metastatic breast cancer who
previously received trastuzumab and a
taxane, separately or in combination.
Subsequent to this approval, the USPTO
received patent term restoration
applications for KADCYLA (U.S. Patent
Nos. 7,097,840 and 8,337,856) from
Genentech, Inc., and the USPTO
requested FDA’s assistance in
determining these patents’ eligibility for
patent term restoration. In a letter dated
May 23, 2014, FDA advised the USPTO
that this human biological product had
undergone a regulatory review period
and that the approval of KADCYLA
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
KADCYLA is 2,594 days. Of this time,
2,414 days occurred during the testing
phase of the regulatory review period,
while 180 days occurred during the
VerDate Sep<11>2014
13:31 Dec 24, 2015
Jkt 238001
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: January 18, 2006. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
January 18, 2006.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): August 27, 2012. The
applicant claims August 24, 2012, as the
date the biologics license application
(BLA) for KADCYLA (BLA 125427) was
initially submitted. However, FDA
records indicate that BLA 125427 was
submitted on August 27, 2012.
3. The date the application was
approved: February 22, 2013. FDA has
verified the applicant’s claim that BLA
125427 was approved on February 22,
2013.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,277 or 60 days of
patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
(see DATES). Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period. To meet its burden, the petition
must be timely (see DATES) and contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Petitions that have not been
made publicly available on https://
www.regulations.gov may be viewed in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
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80775
Dated: December 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–32475 Filed 12–24–15; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
E:\FR\FM\28DEN1.SGM
28DEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
80776
Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Notices
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 (§ 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
§ 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
VerDate Sep<11>2014
13:31 Dec 24, 2015
Jkt 238001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Externally-Led Patient-Focused Drug
Development Meetings
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the opportunity for
externally-led patient-focused drug
development meetings. The PatientFocused Drug Development (PFDD)
initiative is part of FDA’s commitments
under the fifth authorization of the
Prescription Drug User Fee Act (PDUFA
V). The PFDD initiative aims to more
systematically obtain the patient
perspective on specific diseases and
their treatments. FDA recognizes that
there are many more disease areas than
can be addressed in the planned FDA
meetings under PDUFA V. To help
expand the benefits of FDA’s PFDD
initiative, FDA welcomes patient
organizations to identify and organize
patient-focused collaborations to
generate public input on other disease
SUMMARY:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
areas, using the process established
through Patient-Focused Drug
Development as a model.
ADDRESSES: FDA recommends that
patient organizations who are interested
in conducting an externally-led PFDD
meeting initially engage with FDA by
submitting a letter of intent (LOI) to
patientfocused@fda.hhs.gov.
Submission details are outlined on
FDA’s Web site: https://www.fda.gov/
ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm453856.htm.
FOR FURTHER INFORMATION CONTACT:
Pujita Vaidya, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 1144,
Silver Spring, MD 20993–0002, 301–
796–0684.
SUPPLEMENTARY INFORMATION: As part of
its commitments under the Prescription
Drug User Fee Act reauthorization of
2012, FDA has taken several steps to
inform the benefit-risk assessments that
inform CDER’s regulatory decisions
concerning new drugs. Among these
efforts is the PFDD initiative that aims
to more systematically obtain the
patient perspective on specific diseases
and their treatments. FDA has
committed to obtaining the patient
perspective on at least 20 disease areas
during the course of PDUFA V. PFDD
meetings give FDA an important
opportunity to hear directly from
patients, patient advocates, and
caretakers about the symptoms that
matter most to them; the impact the
disease has on patients’ daily lives; and
patients’ experiences with currently
available treatments. The patient
perspective is critical in helping FDA
understand the context in which
regulatory decisions are made for new
drugs. This patient input can inform
FDA’s decisions and oversight both
during drug development and during
our review of a marketing application.
The Agency recognizes that there has
been growing external interest in
expanding efforts to gather patient input
in support of drug development and
evaluation. To help expand the benefits
of FDA’s PFDD initiative, FDA
welcomes patient organizations to
identify and organize patient-focused
collaborations to generate public input
on other disease areas, using the process
established through Patient-Focused
Drug Development as a model. An
externally-led PFDD meeting and any
resulting products (e.g., surveys or
reports) will not be considered FDAsponsored or FDA-endorsed, and FDA
does not guarantee specific involvement
in such meetings. However, FDA will be
E:\FR\FM\28DEN1.SGM
28DEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
