Determination That DEXEDRINE (Dextroamphetamine Sulfate) Oral Solution, 5 Milligrams per 5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 44160-44161 [E7-15236]
Download as PDF
<![CDATA[
44160
Federal Register / Vol. 72, No. 151 / Tuesday, August 7, 2007 / Notices
Consultant Services, Inc., requested that
FDA determine whether PREVACID
NAPRAPAC 250 was withdrawn from
sale for reasons of safety or
effectiveness.
For the reasons outlined previously,
FDA has determined that TAP’s
PREVACID NAPRAPAC 250 was not
withdrawn from sale for reasons of
safety or effectiveness. In support of this
finding, the agency notes that a higher
strength of PREVACID NAPRAPAC 250
[PREVACID NAPRAPAC 500 (15 mg/
500 mg)] is currently being marketed. In
addition, the petitioner identified no
data or information suggesting that
PREVACID NAPRAPAC 250 was
withdrawn from sale for reasons of
safety or effectiveness. FDA’s
independent evaluation of relevant
literature and data has not uncovered
anything that would indicate that this
product was withdrawn for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing agency records
concerning the withdrawal, FDA found
no indication that the decision not to
commercially market PREVACID
NAPRAPAC 250 was a result of any
safety or effectiveness concerns
regarding the product. Accordingly, the
agency will continue to list PREVACID
NAPRAPAC 250 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 PREVACID
NAPRAPAC 250 may be approved by
the agency as long as they meet all
relevant legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for these drug products should be
revised to meet current standards, the
agency will advise ANDA applicants to
submit such labeling.
Dated: July 30, 2007.
Randall W. Lutter
Deputy Commissioner for Policy.
[FR Doc. E7–15233 Filed 8–6–07; 8:45 am]
jlentini on PROD1PC65 with NOTICES
BILLING CODE 4160–01–S
VerDate Aug<31>2005
15:56 Aug 06, 2007
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P–0125]
Determination That DEXEDRINE
(Dextroamphetamine Sulfate) Oral
Solution, 5 Milligrams per 5 Milliliters,
Was Not Withdrawn From Sale for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 DEXEDRINE (dextroamphetamine
sulfate) oral solution, 5 milligrams (mg)
per 5 milliliters (mL), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for
dextroamphetamine sulfate oral
solution, 5 mg/5 mL.
FOR FURTHER INFORMATION CONTACT:
Nikki Mueller, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors 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. Sponsors of
ANDAs 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 generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn from the list if the
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
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).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug.
DEXEDRINE (dextroamphetamine
sulfate) oral solution, 5 mg/5 mL, is the
subject of approved ANDA 83–902 held
by GlaxoSmithKline (GSK). DEXEDRINE
(dextroamphetamine sulfate) oral
solution is indicated for the treatment of
attention deficit hyperactivity disorder
(ADHD). GSK’s ANDA 83–902 was
originally approved in 1976 and was
discontinued in 1988. Lachman
Consultant Services, Inc., submitted a
citizen petition dated March 17, 2006
(Docket No. 2006P–0125/CP1), under 21
CFR 10.30, requesting that the agency
determine, as described in § 314.161,
whether DEXEDRINE
(dextroamphetamine sulfate) oral
solution, 5 mg/5 mL, was withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing agency records, FDA has
determined that GSK’s DEXEDRINE
(dextroamphetamine sulfate) oral
solution, 5 mg/5 mL, was not
withdrawn from sale for reasons of
safety or effectiveness. In support of this
finding, we note that DEXEDRINE
(dextroamphetamine sulfate) is available
in an extended release capsule form and
is a widely used product that has been
marketed for many decades in many
dosage forms. Neither the petition nor
any comment to the petition identified
evidence suggesting that DEXEDRINE
(dextroamphetamine sulfate) oral
solution, 5 mg/5 mL, was withdrawn
from sale for reasons of safety or
effectiveness. FDA has independently
evaluated relevant literature and data
for adverse event reports and has found
no information that would indicate that
DEXEDRINE (dextroamphetamine
sulfate) oral solution, 5 mg/5 mL, was
withdrawn for reasons of safety or
effectiveness.
For the reasons outlined in this
document, FDA determines that GSK’s
DEXEDRINE (dextroamphetamine
sulfate) oral solution, 5 mg/5 mL, was
not withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will continue to list DEXEDRINE
(dextroamphetamine sulfate) oral
E:\FR\FM\07AUN1.SGM
07AUN1
Federal Register / Vol. 72, No. 151 / Tuesday, August 7, 2007 / Notices
solution, 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 DEXEDRINE (dextroamphetamine
sulfate) oral solution, 5 mg/5 mL, may
be approved by the agency as long as
they meet all relevant legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
labeling for these drug products should
be revised to meet current standards, the
agency will advise ANDA applicants to
submit such labeling.
Dated: July 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–15236 Filed 8–6–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Summaries of Medical and Clinical
Pharmacology Reviews of Pediatric
Studies; Availability
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of summaries of medical
and clinical pharmacology reviews of
pediatric studies submitted in
supplements for ACTIQ (fentanyl),
ALDARA (imiquimod), AMBIEN
(zolpidem), COREG (carvedilol),
PROVIGIL (modafinil), and ZYPREXA
(olanzapine). These summaries are
being made available consistent with
the Best Pharmaceuticals for Children
Act (the BPCA). For all pediatric
supplements submitted under the
BPCA, the BPCA requires FDA to make
available to the public a summary of the
medical and clinical pharmacology
reviews of the pediatric studies
conducted for the supplement.
ADDRESSES: Submit written requests for
single copies of the summaries to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Please specify by
product name which summary or
summaries you are requesting. Send one
self-addressed adhesive label to assist
that office in processing your requests.
See the SUPPLEMENTARY INFORMATION
VerDate Aug<31>2005
15:56 Aug 06, 2007
Jkt 211001
section for electronic access to the
summaries.
FOR FURTHER INFORMATION CONTACT:
Grace Carmouze, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6460,
Silver Spring, MD 20993–0002, 301–
796–0700, e-mail:
grace.carmouze@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
summaries of medical and clinical
pharmacology reviews of pediatric
studies conducted for ACTIQ (fentanyl),
ALDARA (imiquimod), AMBIEN
(zolpidem), COREG (carvedilol),
PROVIGIL (modafinil), and ZYPREXA
(olanzapine). The summaries are being
made available consistent with section 9
of the BPCA (Public Law 107–109).
Enacted on January 4, 2002, the BPCA
reauthorizes, with certain important
changes, the pediatric exclusivity
program described in section 505A of
the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 355a). Section
505A of the act permits certain
applications to obtain 6 months of
marketing exclusivity if, in accordance
with the requirements of the statute, the
sponsor submits requested information
relating to the use of the drug in the
pediatric population.
One of the provisions the BPCA
added to the pediatric exclusivity
program pertains to the dissemination of
pediatric information. Specifically, for
all pediatric supplements submitted
under the BPCA, the BPCA requires
FDA to make available to the public a
summary of the medical and clinical
pharmacology reviews of pediatric
studies conducted for the supplement
(21 U.S.C. 355a(m)(1)). The summaries
are to be made available not later than
180 days after the report on the
pediatric study is submitted to FDA (21
U.S.C. 355a(m)(1)). Consistent with this
provision of the BPCA, FDA has posted
on the Internet at https://www.fda.gov/
cder/pediatric/index.htm summaries of
medical and clinical pharmacology
reviews of pediatric studies submitted
in supplements for ACTIQ (fentanyl),
ALDARA (imiquimod), AMBIEN
(zolpidem), COREG (carvedilol),
PROVIGIL (modafinil), and ZYPREXA
(olanzapine). Copies are also available
by mail (see ADDRESSES).
II. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/cder/pediatric/index.htm.
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
44161
Dated: July 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–15234 Filed 8–6–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Poison Control Center Stabilization
and Enhancement Grant Programs
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Response to solicitation of
comments.
AGENCY:
SUMMARY: A notice was published in the
Federal Register (FR) on February 13,
2007, (Vol. 72, p. 6738–6739),
describing HRSA’s proposal to institute
an exception to the Department of
Health and Human Services’ policy
directive governing indirect cost
recovery. The notice requested public
comments on the proposed exception to
Departmental policy requirements to be
sent to HRSA no later than March 15,
2007.
Three comments were received, one
from a Poison Control Center (PCC) host
institution (grant recipient) and two
from individual PCCs. Two of the three
commenters supported HRSA’s plan to
institute an exception from the grants
policy directive, which would
permanently limit indirect cost recovery
to 10 percent for the Poison Control
Center Stabilization and Enhancement
Grant Programs.
Issue: Institution of a 10 Percent Limit
on the Indirect Cost
Comments: Two of the three
commenters fully supported HRSA’s
proposal to permanently limit indirect
cost recovery rates to 10 percent for this
program. One commenter raised
concern that the limitation would
impose greater burdens on the host
institution by shifting the unrecovered
administrative costs to the host
institution. In response, we replied that
the 10 percent limitation had been in
effect since the institution of the award
program.
Agency Response: As noted in the
referenced Federal Register Notice,
since 2001, the HRSA Poison Control
Program has limited indirect costs to 10
percent of the allowable total direct
costs for grantees with negotiated rate
agreements. This limitation on indirect
costs was requested annually because
many PCCs are housed within
universities and hospitals (the official
E:\FR\FM\07AUN1.SGM
07AUN1
]]>Agencies
[Federal Register Volume 72, Number 151 (Tuesday, August 7, 2007)]
[Notices]
[Pages 44160-44161]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15236]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P-0125]
Determination That DEXEDRINE (Dextroamphetamine Sulfate) Oral
Solution, 5 Milligrams per 5 Milliliters, Was 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
DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 milligrams (mg)
per 5 milliliters (mL), was not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for dextroamphetamine sulfate
oral solution, 5 mg/5 mL.
FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors 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. Sponsors of ANDAs 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 generally known as the ``Orange
Book.'' Under FDA regulations, drugs are withdrawn 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).
Under Sec. 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness before an ANDA that refers to that listed drug
may be approved. FDA may not approve an ANDA that does not refer to a
listed drug.
DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL, is
the subject of approved ANDA 83-902 held by GlaxoSmithKline (GSK).
DEXEDRINE (dextroamphetamine sulfate) oral solution is indicated for
the treatment of attention deficit hyperactivity disorder (ADHD). GSK's
ANDA 83-902 was originally approved in 1976 and was discontinued in
1988. Lachman Consultant Services, Inc., submitted a citizen petition
dated March 17, 2006 (Docket No. 2006P-0125/CP1), under 21 CFR 10.30,
requesting that the agency determine, as described in Sec. 314.161,
whether DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL,
was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing agency
records, FDA has determined that GSK's DEXEDRINE (dextroamphetamine
sulfate) oral solution, 5 mg/5 mL, was not withdrawn from sale for
reasons of safety or effectiveness. In support of this finding, we note
that DEXEDRINE (dextroamphetamine sulfate) is available in an extended
release capsule form and is a widely used product that has been
marketed for many decades in many dosage forms. Neither the petition
nor any comment to the petition identified evidence suggesting that
DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL, was
withdrawn from sale for reasons of safety or effectiveness. FDA has
independently evaluated relevant literature and data for adverse event
reports and has found no information that would indicate that DEXEDRINE
(dextroamphetamine sulfate) oral solution, 5 mg/5 mL, was withdrawn for
reasons of safety or effectiveness.
For the reasons outlined in this document, FDA determines that
GSK's DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL,
was not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will continue to list DEXEDRINE
(dextroamphetamine sulfate) oral
[[Page 44161]]
solution, 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 DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5
mL, may be approved by the agency as long as they meet all relevant
legal and regulatory requirements for the approval of ANDAs. If FDA
determines that labeling for these drug products should be revised to
meet current standards, the agency will advise ANDA applicants to
submit such labeling.
Dated: July 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-15236 Filed 8-6-07; 8:45 am]
BILLING CODE 4160-01-S
