Determination That SUBOXONE (Buprenorphine Hydrochloride and Naloxone Hydrochloride) Sublingual Tablets, 2 Milligrams/0.5 Milligrams and 8 Milligrams/2 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 34108-34109 [2013-13446]
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34108
Federal Register / Vol. 78, No. 109 / Thursday, June 6, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–P–1034]
Determination That SUBOXONE
(Buprenorphine Hydrochloride and
Naloxone Hydrochloride) Sublingual
Tablets, 2 Milligrams/0.5 Milligrams
and 8 Milligrams/2 Milligrams, 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Not Withdrawn From Sale for Reasons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) has determined
that SUBOXONE (buprenorphine
hydrochloride (HCl) and naloxone HCl)
sublingual tablets, 2 milligrams (mg)/0.5
mg and 8 mg/2 mg, were not withdrawn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
buprenorphine HCl and naloxone HCl
sublingual tablets, 2 mg/0.5 mg and 8
mg/2 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
David E. Markert, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3602.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
I. Background
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
VerDate Mar<15>2010
17:35 Jun 05, 2013
Jkt 229001
‘‘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.
SUBOXONE (buprenorphine HCl and
naloxone HCl) sublingual tablets, 2 mg/
0.5 mg and 8 mg/2 mg, are the subject
of NDA 20–733, held by Reckitt
Benckiser Pharmaceuticals, Inc.
(Reckitt), and initially approved on
October 8, 2002. SUBOXONE is
indicated for maintenance treatment of
opioid dependence.
In a letter dated September 18, 2012,
Reckitt notified FDA that SUBOXONE
(buprenorphine HCl and naloxone HCl)
sublingual tablets, 2 mg/0.5 mg and 8
mg/2 mg, were being discontinued.
Shortly thereafter, Reckitt publicly
announced that it was discontinuing
this product for safety reasons and that
it had submitted a citizen petition
requesting that FDA require all
manufacturers of buprenorphinecontaining products for the treatment of
opioid dependence to implement
certain public health safeguards (Ref.
1).1 Reckitt later informed the Agency
that it ceased distributing SUBOXONE
sublingual tablets in March 2013, at
which time FDA moved the product to
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Lachman Consultant Services, Inc.
(Lachman), submitted a citizen petition
dated September 27, 2012 (Docket No.
FDA–2012–P–1034), under 21 CFR
10.30, requesting that the Agency
1 The citizen petition (Docket No. FDA–2012–P–
1028), which was submitted on September 25, 2012,
also requested that FDA refuse to approve any
ANDAs for buprenorphine HCl and naloxone HCl
products for opioid dependence until the Agency
determined whether SUBOXONE sublingual tablets
were discontinued for safety reasons. In its
February 22, 2013, response to the citizen petition,
FDA concluded that this request was premature
because Reckitt had not yet withdrawn SUBOXONE
sublingual tablets from sale. Nonetheless, the
Agency conducted a full review and analysis of the
safety issues raised in Reckitt’s citizen petition and
determined, on the basis of the data available at that
time, that withdrawal of SUBOXONE sublingual
tablets from sale was not necessary for reasons of
safety.
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
determine whether SUBOXONE
(buprenorphine HCl and naloxone HCl)
sublingual tablets, 2 mg/0.5 mg and 8
mg/2 mg, were withdrawn from sale for
reasons of safety or effectiveness. The
petitioner noted that Reckitt had
publicly announced that it was
discontinuing this product.
After considering Lachman’s citizen
petition and reviewing our records,
including the safety analysis that the
Agency prepared in connection with
Reckitt’s citizen petition, FDA has
determined under § 314.161 that
SUBOXONE (buprenorphine HCl and
naloxone HCl) sublingual tablets, 2 mg/
0.5 mg and 8 mg/2 mg, were not
withdrawn for reasons of safety. We
described the basis for this
determination in our letter response to
Reckitt’s citizen petition (available at
https://www.regulations.gov under
Docket No. FDA–2012–P–1028). Since
the issuance of that response, we have
updated our reviews of relevant
literature and data on this product. We
found no additional information during
this process that would indicate that
SUBOXONE (buprenorphine HCl and
naloxone HCl) sublingual tablets, 2 mg/
0.5 mg and 8 mg/2 mg, were, or should
have been, withdrawn from sale for
reasons of safety.
FDA has also determined under
§ 314.161 that SUBOXONE
(buprenorphine HCl and naloxone HCl)
sublingual tablets, 2 mg/0.5 mg and 8
mg/2 mg, were not withdrawn for
reasons of effectiveness. We have
reviewed our records and other relevant
data sources, and have found no
information that would indicate that
this product was ineffective as a
maintenance treatment of opioid
dependence.
Accordingly, the Agency will
continue to list SUBOXONE
(buprenorphine HCl and naloxone HCl)
sublingual tablets, 2 mg/0.5 mg and 8
mg/2 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 SUBOXONE
(buprenorphine HCl and naloxone HCl)
sublingual tablets, 2 mg/0.5 mg and 8
mg/2 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.
E:\FR\FM\06JNN1.SGM
06JNN1
Federal Register / Vol. 78, No. 109 / Thursday, June 6, 2013 / Notices
II. References
The following reference has been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and is available
electronically at https://
www.regulations.gov. (FDA has verified
the Web site address in this reference
section, but FDA is not responsible for
any subsequent changes to the Web site
after this document publishes in the
Federal Register.)
1. ‘‘Further US RB Pharmaceuticals
Announcement,’’ https://www.rb.com/site/
rkbr/templates/mediainvestors
general2.aspx?pageid=1332&cc=GB,
Reckitt Benckiser Group plc, September 25,
2012. Web. May 17, 2013.
Dated: May 31, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2013–13446 Filed 6–5–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0012]
‘‘Script Your Future’’ Medication
Adherence Campaign
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for the
continuing support of a national effort
to promote the importance of
medication adherence to enhance the
health of Americans. Medication
adherence is taking medicine as
directed to treat an illness or disease in
order to get the best health outcome
possible for each patient. Nearly three
out of four Americans report that they
do not take their medication as directed.
One in three people never fill their
prescriptions. The annual price tag for
medication adherence failure is
estimated to be $290 billion, and the
impact on the medical system and
patients from this lack of adherence may
result in relapses or recurrences of
medical symptoms, increases in hospital
visits, or even death. FDA is committed
to addressing this issue, which has
enormous implications for public health
and the U.S. economy, by, in part,
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:35 Jun 05, 2013
Jkt 229001
continuing its financial and other
contributions to a carefully planned,
well-executed effective national
campaign begun in 2010 by the National
Consumers League (NCL) called ‘‘Script
Your Future’’.
To continue and enhance this
important public health initiative, the
Division of Health Communications
(DHC)/Office of Communications
(OCOMM)/Center for Drug Evaluation
and Research (CDER) in FDA seeks to
assist the National Consumers League in
the development of new online
resources and tools for patients,
engagement of public and private
partners to build on and complement
existing medication adherence
programs, education of health care
professionals with strategies to share
with patients, continuous evaluation of
the campaign to enhance and improve
it, expansion of public-private
partnerships, strengthening of this
national forum focused on informing
consumers about medication adherence,
and tailoring messaging to
subpopulations of consumers who may
need adaptations or special efforts to
inform and educate them.
DATES: Important dates are as follows:
1. The application due date is July 1,
2013.
2. The anticipated start date is August
2013.
3. The opening date is the date this
announcement is published in the
Federal Register.
4. The expiration date is July 2, 2013.
ADDRESSES: Submit the paper
application to: Gladys Melendez, Grants
Management (HFA–500), Food and Drug
Administration, 5630 Fishers Lane, Rm.
2032, Rockville, MD 20857; and a copy
to Elaine Frost, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Rm. 1140, Silver
Spring, MD 20903. For more
information, see section III of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Paula Rausch, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Rm. 4110, Silver
Spring, MD 20903, 301–796–3121; or
Gladys Melendez, Grants Management
Branch (HFA–500), Food and Drug
Administration, 5630 Fishers Lane, Rm.
2032, Rockville, MD 20857, 301–827–
7175.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
obtain the full FOA from
gladys.bohler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
34109
I. Funding Opportunity Description
Request for Application: FDA–RFA–
13–027.
Catalog of Federal Domestic Assistance:
93.103
A. Background
In order to fulfill FDA’s mission to
protect public health by assuring the
safety, efficacy, and security of human
drugs; and helping the public to obtain
the accurate, science-based information
they need to use medications in ways
that maintain and improve their health,
FDA seeks to continue its participation
in a national campaign aimed at
promoting the importance of medication
adherence to enhance the health of
Americans.
FDA recognizes medication adherence
as a formidable health problem that
results in health system and human
costs that adversely impact our nation.
FDA has a responsibility as a public
health agency to educate and inform the
public and health professionals about
the importance of medication
adherence. Since 2010, FDA has been a
key government stakeholder in the
NCL’s initiative, along with other major
government agencies and private and
nonprofit organizations, to address the
issue of poor medication adherence.
FDA is committed to educating and
informing the public about this issue,
including key subpopulations such as
those with low literacy and health
literacy, or that faces health disparities
or is economically disadvantaged.
The NCL is the nation’s oldest
consumer organization. With FDA and
its other government partners, NCL
launched its nationwide ‘‘Script Your
Future’’ campaign in 2010 to address
the issue of poor medication adherence.
NCL possesses an extensive research
and evaluation framework from past
medication outreach efforts that helped
ensure the campaign’s medication
adherence messages and materials are
based on sound communication science.
In addition, NCL assembled a coalition
of more than 130 public-private partners
to mobilize resources that can increase
awareness and outreach to the public far
beyond what FDA would be able to do
alone to promote increased
understanding and positive actions
among the general public and health
professionals related to this critical
issue. Future NCL plans are in sync
with FDA goals for a national
medication adherence campaign and
FDA seeks to enhance this carefully
designed communications intervention.
FDA has been and remains a key partner
with NCL on issues pertaining to the
safe use of medicines.
E:\FR\FM\06JNN1.SGM
06JNN1
Agencies
[Federal Register Volume 78, Number 109 (Thursday, June 6, 2013)]
[Notices]
[Pages 34108-34109]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13446]
[[Page 34108]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-P-1034]
Determination That SUBOXONE (Buprenorphine Hydrochloride and
Naloxone Hydrochloride) Sublingual Tablets, 2 Milligrams/0.5 Milligrams
and 8 Milligrams/2 Milligrams, 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) has determined that
SUBOXONE (buprenorphine hydrochloride (HCl) and naloxone HCl)
sublingual tablets, 2 milligrams (mg)/0.5 mg and 8 mg/2 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 buprenorphine HCl and naloxone HCl sublingual
tablets, 2 mg/0.5 mg and 8 mg/2 mg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: David E. Markert, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3602.
SUPPLEMENTARY INFORMATION:
I. Background
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.
SUBOXONE (buprenorphine HCl and naloxone HCl) sublingual tablets, 2
mg/0.5 mg and 8 mg/2 mg, are the subject of NDA 20-733, held by Reckitt
Benckiser Pharmaceuticals, Inc. (Reckitt), and initially approved on
October 8, 2002. SUBOXONE is indicated for maintenance treatment of
opioid dependence.
In a letter dated September 18, 2012, Reckitt notified FDA that
SUBOXONE (buprenorphine HCl and naloxone HCl) sublingual tablets, 2 mg/
0.5 mg and 8 mg/2 mg, were being discontinued. Shortly thereafter,
Reckitt publicly announced that it was discontinuing this product for
safety reasons and that it had submitted a citizen petition requesting
that FDA require all manufacturers of buprenorphine-containing products
for the treatment of opioid dependence to implement certain public
health safeguards (Ref. 1).\1\ Reckitt later informed the Agency that
it ceased distributing SUBOXONE sublingual tablets in March 2013, at
which time FDA moved the product to the ``Discontinued Drug Product
List'' section of the Orange Book.
---------------------------------------------------------------------------
\1\ The citizen petition (Docket No. FDA-2012-P-1028), which was
submitted on September 25, 2012, also requested that FDA refuse to
approve any ANDAs for buprenorphine HCl and naloxone HCl products
for opioid dependence until the Agency determined whether SUBOXONE
sublingual tablets were discontinued for safety reasons. In its
February 22, 2013, response to the citizen petition, FDA concluded
that this request was premature because Reckitt had not yet
withdrawn SUBOXONE sublingual tablets from sale. Nonetheless, the
Agency conducted a full review and analysis of the safety issues
raised in Reckitt's citizen petition and determined, on the basis of
the data available at that time, that withdrawal of SUBOXONE
sublingual tablets from sale was not necessary for reasons of
safety.
---------------------------------------------------------------------------
Lachman Consultant Services, Inc. (Lachman), submitted a citizen
petition dated September 27, 2012 (Docket No. FDA-2012-P-1034), under
21 CFR 10.30, requesting that the Agency determine whether SUBOXONE
(buprenorphine HCl and naloxone HCl) sublingual tablets, 2 mg/0.5 mg
and 8 mg/2 mg, were withdrawn from sale for reasons of safety or
effectiveness. The petitioner noted that Reckitt had publicly announced
that it was discontinuing this product.
After considering Lachman's citizen petition and reviewing our
records, including the safety analysis that the Agency prepared in
connection with Reckitt's citizen petition, FDA has determined under
Sec. 314.161 that SUBOXONE (buprenorphine HCl and naloxone HCl)
sublingual tablets, 2 mg/0.5 mg and 8 mg/2 mg, were not withdrawn for
reasons of safety. We described the basis for this determination in our
letter response to Reckitt's citizen petition (available at https://www.regulations.gov under Docket No. FDA-2012-P-1028). Since the
issuance of that response, we have updated our reviews of relevant
literature and data on this product. We found no additional information
during this process that would indicate that SUBOXONE (buprenorphine
HCl and naloxone HCl) sublingual tablets, 2 mg/0.5 mg and 8 mg/2 mg,
were, or should have been, withdrawn from sale for reasons of safety.
FDA has also determined under Sec. 314.161 that SUBOXONE
(buprenorphine HCl and naloxone HCl) sublingual tablets, 2 mg/0.5 mg
and 8 mg/2 mg, were not withdrawn for reasons of effectiveness. We have
reviewed our records and other relevant data sources, and have found no
information that would indicate that this product was ineffective as a
maintenance treatment of opioid dependence.
Accordingly, the Agency will continue to list SUBOXONE
(buprenorphine HCl and naloxone HCl) sublingual tablets, 2 mg/0.5 mg
and 8 mg/2 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
SUBOXONE (buprenorphine HCl and naloxone HCl) sublingual tablets, 2 mg/
0.5 mg and 8 mg/2 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.
[[Page 34109]]
II. References
The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at https://www.regulations.gov. (FDA has
verified the Web site address in this reference section, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)
1. ``Further US RB Pharmaceuticals Announcement,'' https://www.rb.com/site/rkbr/templates/mediainvestorsgeneral2.aspx?pageid=1332&cc=GB, Reckitt Benckiser
Group plc, September 25, 2012. Web. May 17, 2013.
Dated: May 31, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-13446 Filed 6-5-13; 8:45 am]
BILLING CODE 4160-01-P