Determination That HYCODAN (Hydrocodone Bitartrate and Homatropine Methylbromide) Tablets, 5 Milligrams/1.5 Milligrams, and HYCODAN (Hydrocodone Bitartrate and Homatropine Methylbromide) Oral Solution, 5 Milligrams/5 Milliliters and 1.5 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 82302-82303 [2011-33549]
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82302
Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices
the FD&C Act, FDA is authorized to
exempt an HUD from the effectiveness
requirements of sections 514 and 515 of
the FD&C Act (21 U.S.C. 360d and 360e)
provided that the device: (1) Is used to
treat or diagnose a disease or condition
that affects fewer than 4,000 individuals
in the United States; (2) would not be
available to a person with such a disease
or condition unless an exemption is
granted because there is no comparable
device other than another HUD
approved under this exemption that is
available to treat or diagnose the disease
or condition; and (3) will not expose
patients to an unreasonable or
significant risk of illness or injury with
the probable benefit to health from
using the device outweighing the risk of
injury or illness from its use. This takes
into account the probable risks and
benefits of currently available devices or
alternative forms of treatment.
The information collected will assist
FDA in making determinations on the
following: (1) Whether to grant HUD
designation of a medical device; (2)
exempt an HUD from the effectiveness
requirements under sections 514 and
515 of the FD&C Act, provided that the
device meets requirements set forth
under section 520(m) of the FD&C Act;
and (3) whether to grant marketing
approval(s) for the HUD. Failure to
collect this information would prevent
FDA from making a determination on
the factors listed previously in this
document. Further, the collected
information would also enable FDA to
determine whether the holder of an
HUD is in compliance with the HUD
provisions under section 520(m) of the
FD&C Act.
The number of respondents in tables
1 and 2 of this document are an average
from data for the previous 3 years, i.e.,
fiscal years 2008 to 2010. The number
of annual reports submitted under
section 814.126(b)(1) in table 1 reflects
43 respondents with approved HUD
applications. Likewise, under section
814.126(b)(2) in table 2, the number of
recordkeepers is 43.
In the Federal Register of September
7, 2011 (76 FR 55394), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
814.102 ................................................................................
814.104 ................................................................................
814.106 ................................................................................
814.108 ................................................................................
814.116(e)(3) .......................................................................
814.124(a) ............................................................................
814.124(b) ............................................................................
814.126(b)(1) .......................................................................
17
5
5
47
3
22
12
43
1
1
5
1
1
1
1
1
17
5
25
47
3
22
12
43
40
320
50
80
1
1
2
120
680
1,600
1,250
3,760
3
22
24
5,160
Total ..............................................................................
........................
........................
........................
........................
12,499
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeeper
21 CFR Section
814.126(b)(2) .......................................................................
1 There
43
Total annual
records
1
43
Average
burden per
recordkeeping
2
Total hours
86
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–33551 Filed 12–29–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–P–0555]
BILLING CODE 4160–01–P
srobinson on DSK4SPTVN1PROD with NOTICES
Number of
records per
recordkeeper
Determination That HYCODAN
(Hydrocodone Bitartrate and
Homatropine Methylbromide) Tablets,
5 Milligrams/1.5 Milligrams, and
HYCODAN (Hydrocodone Bitartrate
and Homatropine Methylbromide) Oral
Solution, 5 Milligrams/5 Milliliters and
1.5 Milligrams/5 Milliliters, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Mar<15>2010
19:02 Dec 29, 2011
Jkt 226001
PO 00000
Notice.
Frm 00035
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA) has determined
that HYCODAN (hydrocodone bitartrate
and homatropine methylbromide)
tablets, 5 milligrams (mg)/1.5 mg, and
HYCODAN (hydrocodone bitartrate and
homatropine methylbromide) oral
solution, 5 mg/5 milliliters (mL) and 1.5
mg/5 mL, were not withdrawn from sale
for reasons of safety or effectiveness.
This determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for hydrocodone
bitartrate and homatropine
methylbromide tablets, 5 mg/1.5 mg,
and HYCODAN (hydrocodone bitartrate
and homatropine methylbromide) oral
solution, 5 mg/5 mL and 1.5 mg/5 mL,
if all other legal and regulatory
requirements are met.
SUMMARY:
E:\FR\FM\30DEN1.SGM
30DEN1
Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices
srobinson on DSK4SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Kristiana Brugger, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6262,
Silver Spring, MD 20993–0002, (301)
796–3601.
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 only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
HYCODAN (hydrocodone bitartrate
and homatropine methylbromide)
tablets, 5 mg/1.5 mg, and HYCODAN
(hydrocodone bitartrate and
homatropine methylbromide) oral
solution, 5 mg/5 mL and 1.5 mg/5 mL,
are the subject of NDA 05–213, held by
Endo Pharmaceuticals, and initially
approved on March 23, 1943. In 1982,
a Drug Efficacy Study Implementation
VerDate Mar<15>2010
19:02 Dec 29, 2011
Jkt 226001
review concluded that HYCODAN
syrup, tablets, and powder were
effective ‘‘for the symptomatic relief of
cough.’’ (47 FR 23809, June 1, 1982).
Subsequently, the sponsor submitted an
NDA for HYCODAN (hydrocodone
bitartrate and homatropine
methylbromide) tablets, 5 mg/1.5 mg,
and HYCODAN (hydrocodone bitartrate
and homatropine methylbromide) oral
solution, 5 mg/5 mL and 1.5 mg/5 mL,
which was approved on July 26, 1988.
HYCODAN is indicated for the
symptomatic relief of cough in adults
and children 6 years of age and older.
In a letter dated January 4, 2008, Endo
Pharmaceuticals notified FDA that
HYCODAN (hydrocodone bitartrate and
homatropine methylbromide) tablets, 5
mg/1.5 mg, were being discontinued,
and FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. Vintage
Pharmaceutical, Inc., submitted a
citizen petition dated October 15, 2008
(Docket No. FDA–2008–P–0555), under
21 CFR 10.30, requesting that the
Agency determine whether HYCODAN
(hydrocodone bitartrate and
homatropine methylbromide) tablets, 5
mg/1.5 mg, were withdrawn from sale
for reasons of safety or effectiveness.
Although the citizen petition did not
request it, FDA has determined, on its
own initiative, whether the oral solution
dosage form was withdrawn for safety or
effectiveness reasons.
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 HYCODAN (hydrocodone
bitartrate and homatropine
methylbromide) tablets, 5 mg/1.5 mg,
and HYCODAN (hydrocodone bitartrate
and homatropine methylbromide) oral
solution, 5 mg/5 mL and 1.5 mg/5 mL,
were not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that HYCODAN
(hydrocodone bitartrate and
homatropine methylbromide) tablets, 5
mg/1.5 mg, or HYCODAN (hydrocodone
bitartrate and homatropine
methylbromide) oral solution, 5 mg/5
mL and 1.5 mg/5 mL, were withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
HYCODAN (hydrocodone bitartrate and
homatropine methylbromide) tablets, 5
mg/1.5 mg, and HYCODAN
(hydrocodone bitartrate and
homatropine methylbromide) oral
solution, 5 mg/5 mL and 1.5 mg/5 mL,
from sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
82303
events. We have found no information
that would indicate that these products
were withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list HYCODAN
(hydrocodone bitartrate and
homatropine methylbromide) tablets, 5
mg/1.5 mg, and HYCODAN
(hydrocodone bitartrate and
homatropine methylbromide) oral
solution, 5 mg/5 mL and 1.5 mg/5 mL,
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 HYCODAN (hydrocodone bitartrate
and homatropine methylbromide)
tablets, 5 mg/1.5 mg, or HYCODAN
(hydrocodone bitartrate and
homatropine methylbromide) oral
solution, 5 mg/5 mL and 1.5 mg/5 mL,
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 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–33549 Filed 12–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0868]
Draft Guidance for Industry on
Responding to Unsolicited Requests
for Off-Label Information About
Prescription Drugs and Medical
Devices; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Responding to
Unsolicited Requests for Off-Label
Information About Prescription Drugs
and Medical Devices.’’ This draft
guidance responds to stakeholder
requests for specific guidance on FDA’s
current views on how manufacturers
and distributors (firms) of prescription
human and animal drug products and
SUMMARY:
E:\FR\FM\30DEN1.SGM
30DEN1
]]>Agencies
[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Notices]
[Pages 82302-82303]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33549]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-P-0555]
Determination That HYCODAN (Hydrocodone Bitartrate and
Homatropine Methylbromide) Tablets, 5 Milligrams/1.5 Milligrams, and
HYCODAN (Hydrocodone Bitartrate and Homatropine Methylbromide) Oral
Solution, 5 Milligrams/5 Milliliters and 1.5 Milligrams/5 Milliliters,
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
HYCODAN (hydrocodone bitartrate and homatropine methylbromide) tablets,
5 milligrams (mg)/1.5 mg, and HYCODAN (hydrocodone bitartrate and
homatropine methylbromide) oral solution, 5 mg/5 milliliters (mL) and
1.5 mg/5 mL, were not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for hydrocodone bitartrate and
homatropine methylbromide tablets, 5 mg/1.5 mg, and HYCODAN
(hydrocodone bitartrate and homatropine methylbromide) oral solution, 5
mg/5 mL and 1.5 mg/5 mL, if all other legal and regulatory requirements
are met.
[[Page 82303]]
FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6262, Silver Spring, MD 20993-0002, (301)
796-3601.
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 only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
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.
HYCODAN (hydrocodone bitartrate and homatropine methylbromide)
tablets, 5 mg/1.5 mg, and HYCODAN (hydrocodone bitartrate and
homatropine methylbromide) oral solution, 5 mg/5 mL and 1.5 mg/5 mL,
are the subject of NDA 05-213, held by Endo Pharmaceuticals, and
initially approved on March 23, 1943. In 1982, a Drug Efficacy Study
Implementation review concluded that HYCODAN syrup, tablets, and powder
were effective ``for the symptomatic relief of cough.'' (47 FR 23809,
June 1, 1982). Subsequently, the sponsor submitted an NDA for HYCODAN
(hydrocodone bitartrate and homatropine methylbromide) tablets, 5 mg/
1.5 mg, and HYCODAN (hydrocodone bitartrate and homatropine
methylbromide) oral solution, 5 mg/5 mL and 1.5 mg/5 mL, which was
approved on July 26, 1988. HYCODAN is indicated for the symptomatic
relief of cough in adults and children 6 years of age and older.
In a letter dated January 4, 2008, Endo Pharmaceuticals notified
FDA that HYCODAN (hydrocodone bitartrate and homatropine methylbromide)
tablets, 5 mg/1.5 mg, were being discontinued, and FDA moved the drug
product to the ``Discontinued Drug Product List'' section of the Orange
Book. Vintage Pharmaceutical, Inc., submitted a citizen petition dated
October 15, 2008 (Docket No. FDA-2008-P-0555), under 21 CFR 10.30,
requesting that the Agency determine whether HYCODAN (hydrocodone
bitartrate and homatropine methylbromide) tablets, 5 mg/1.5 mg, were
withdrawn from sale for reasons of safety or effectiveness. Although
the citizen petition did not request it, FDA has determined, on its own
initiative, whether the oral solution dosage form was withdrawn for
safety or effectiveness reasons.
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 HYCODAN (hydrocodone bitartrate and
homatropine methylbromide) tablets, 5 mg/1.5 mg, and HYCODAN
(hydrocodone bitartrate and homatropine methylbromide) oral solution, 5
mg/5 mL and 1.5 mg/5 mL, were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that HYCODAN (hydrocodone bitartrate and
homatropine methylbromide) tablets, 5 mg/1.5 mg, or HYCODAN
(hydrocodone bitartrate and homatropine methylbromide) oral solution, 5
mg/5 mL and 1.5 mg/5 mL, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of HYCODAN (hydrocodone bitartrate and
homatropine methylbromide) tablets, 5 mg/1.5 mg, and HYCODAN
(hydrocodone bitartrate and homatropine methylbromide) oral solution, 5
mg/5 mL and 1.5 mg/5 mL, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
these products were withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list HYCODAN (hydrocodone
bitartrate and homatropine methylbromide) tablets, 5 mg/1.5 mg, and
HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral
solution, 5 mg/5 mL and 1.5 mg/5 mL, 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 HYCODAN (hydrocodone bitartrate and
homatropine methylbromide) tablets, 5 mg/1.5 mg, or HYCODAN
(hydrocodone bitartrate and homatropine methylbromide) oral solution, 5
mg/5 mL and 1.5 mg/5 mL, 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 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33549 Filed 12-29-11; 8:45 am]
BILLING CODE 4160-01-P
