Determination That Celestone Soluspan (Betamethasone Sodium Phosphate and Betamethasone Acetate) Injection and Celestone (Betamethasone Sodium Phosphate) Injection Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 2047-2048 [E6-178]
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2047
Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Respondents
Office-based physicians:
Induction Interview ....................................................................................
Patient Record Form ................................................................................
CCSS ........................................................................................................
Community Health Center:
Induction Interview—Directors ..................................................................
Induction Interview—Providers .................................................................
Patient Record Form ................................................................................
CCSS ........................................................................................................
Total ...................................................................................................
Dated: January 5, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–211 Filed 1–11–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2004P–0406 and 2004P–0407]
Determination That Celestone
Soluspan (Betamethasone Sodium
Phosphate and Betamethasone
Acetate) Injection and Celestone
(Betamethasone Sodium Phosphate)
Injection Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
erjones on PROD1PC68 with NOTICES
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing its
determination that two drug products—
Celestone Soluspan (betamethasone
sodium phosphate and betamethasone
acetate) injection and Celestone
(betamethasone sodium phosphate)
injection—were not withdrawn from
sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
betamethasone sodium phosphate and
betamethasone acetate injection and
betamethasone sodium phosphate
injection if all other legal and regulatory
requirements are met. However, in
considering whether to file an ANDA for
betamethasone sodium phosphate and
betamethasone acetate injection, future
applicants are advised that Celestone
Soluspan injection may not be
commercially available because, under a
consent decree between FDA and the
VerDate Aug<31>2005
15:02 Jan 11, 2006
Jkt 208001
28/60
4/60
15/60
1,563
5,026
178
104
312
312
312
1
1
30
1
20/60
35/60
5/60
15/60
35
182
780
78
........................
........................
........................
7,842
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 under a new drug
application (NDA). Sponsors of ANDAs
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of an 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 (the act)
Frm 00035
Fmt 4703
Total burden
hours
1
30
1
manufacturer, it is being made available
in certain instances of medical necessity
only. The reasons for its unavailability
are not safety or effectiveness
considerations associated with the drug
product in general, but specific to the
manufacturer. An ANDA applicant who
is unable to obtain Celestone Soluspan
injection for bioequivalence testing
must contact the Office of Generic Drugs
for a determination of what is necessary
to show bioavailability and same
therapeutic effect. If the reference listed
drug (RLD) product becomes
commercially available prior to ANDA
approval, the ANDA applicant will need
to show bioequivalence to the RLD
product.
FOR FURTHER INFORMATION CONTACT:
Carol E. Drew, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
PO 00000
Avg. burden/
response
(in hrs)
3,350
2,513
712
SUPPLEMENTARY INFORMATION:
Notice.
Number of
responses/respondent
Sfmt 4703
(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).
Regulations also provide that the agency
must make a determination as to
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
(§ 314.161(a)(1) (21 CFR 314.161(a)(1))).
FDA may not approve an ANDA that
does not refer to a listed drug.
On September 7, 2004, Hikma
Farmaceutica (Portugal) LDA submitted
two citizen petitions (Docket Nos.
2004P–0406/CP1 and 2004P–0407/CP1)
to FDA under 21 CFR 10.30 requesting
that the agency determine whether
Celestone Soluspan (betamethasone
sodium phosphate and betamethasone
acetate) injection equivalent to 6
milligrams (mg) base/milliliter (mL)
(NDA 14–602) and Celestone
(betamethasone sodium phosphate)
injection equivalent to 3 mg base/mL
(NDA 17–561), both manufactured by
Schering-Plough Corp. (Schering), were
withdrawn from sale for reasons of
safety or effectiveness. Celestone
Soluspan injection and Celestone
injection are corticosteroids used for
their anti-inflammatory effects in
disorders of many organ systems.
Schering ceased manufacture of
Celestone injection in March 2004, and
it was moved from the prescription drug
product list to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
E:\FR\FM\12JAN1.SGM
12JAN1
2048
Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices
erjones on PROD1PC68 with NOTICES
Schering has not discontinued
manufacture of Celestone Soluspan
injection; however, as a result of a May
2002 consent decree addressing
manufacturing concerns, Schering’s
manufacture and distribution of
Celestone Soluspan injection has been
limited to providing the drug for certain
medically necessary uses under a
limited distribution program. Celestone
Soluspan injection is being distributed
as medically necessary for the following
uses: (1) Neonatal use (fetal lung
maturation), (2) epidural route for the
management of pain due to
radiculopathy in patients not responsive
to systemic drug therapy and other
adjunctive therapies, and (3) intraarticular and soft tissue injections for
synovitis of osteoarthritis, acute gouty
arthritis, nonspecific tenosynovitis, and
acute and subacute bursitis. Information
regarding the current distribution for
Celestone Soluspan injection by
Schering can be found on FDA’s Drug
Shortage Web site: https://www.fda.gov/
cder/drug/shortages/celestone.htm.
FDA has reviewed its records and,
under § 314.161, has determined that
Celestone Soluspan (betamethasone
sodium phosphate and betamethasone
acetate) injection and Celestone
(betamethasone sodium phosphate)
injection were not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the agency will continue
to list betamethasone sodium phosphate
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 betamethasone sodium phosphate
may be approved by the agency. ANDAs
that refer to betamethasone sodium
phosphate and betamethasone acetate
injection also may be approved by the
VerDate Aug<31>2005
17:40 Jan 11, 2006
Jkt 208001
agency; however, FDA recommends that
in considering whether to file an ANDA
for this drug product, future applicants
be advised that the RLD may not be
commercially available because it is
being made available in certain
instances of medical necessity only. An
ANDA applicant who is unable to
obtain Celestone Soluspan injection for
bioequivalence testing must contact the
Office of Generic Drugs for a
determination of what showing is
necessary to satisfy the requirements of
section 505(j)(2)(A)(iv) of the act. If an
ANDA is approved without a showing
of bioequivalence, the approved product
will not be granted an AB rating in the
Orange Book. Future applicants for
betamethasone sodium phosphate and
betamethasone acetate injection are
advised that if the RLD product becomes
commercially available prior to ANDA
approval, the ANDA applicant will need
to show bioequivalence to the RLD
product.
Dated: January 4, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–178 Filed 1–11–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FDA–225–05–8006]
Memorandum of Understanding
Between the United States Food and
Drug Administration Department of
Health and Human Services and the
Australian Pesticides and Veterinary
Medicines Authority, Australia
AGENCY:
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between the
United States Food and Drug
Administration, Department of Health
and Human Services and the Australian
Pesticides and Veterinary Medicines
Authority (APVMA), Australia. This
MOU is intended to establish an
information-sharing arrangement
between APVMA and FDA. The
Participants intend to strengthen the
exchange of knowledge and expertise to
enhance the efficiency and effectiveness
of their respective roles. This MOU
focuses on cooperation in relations to
the operational aspects of animal drug
regulation and is not intended to cover
broader government regulatory policy or
to cover areas not falling under the
common jurisdictional purview of the
Participants.
The agreement became effective
October 20, 2005.
DATES:
FOR FURTHER INFORMATION CONTACT:
Matthew E. Eckel, Office of
International Programs, Food and Drug
Administration, 5600 Fishers Lane
(HFG–1), Rockville MD, 20857, 301–
827–4480, FAX 301–480–0716.
In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
SUPPLEMENTARY INFORMATION:
Dated: January 4, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–S
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00036
Fmt 4703
Sfmt 4703
E:\FR\FM\12JAN1.SGM
12JAN1
]]>Agencies
[Federal Register Volume 71, Number 8 (Thursday, January 12, 2006)]
[Notices]
[Pages 2047-2048]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-178]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2004P-0406 and 2004P-0407]
Determination That Celestone Soluspan (Betamethasone Sodium
Phosphate and Betamethasone Acetate) Injection and Celestone
(Betamethasone Sodium Phosphate) Injection 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) is announcing its
determination that two drug products--Celestone Soluspan (betamethasone
sodium phosphate and betamethasone acetate) injection and Celestone
(betamethasone sodium phosphate) injection--were not withdrawn from
sale for reasons of safety or effectiveness. This determination will
allow FDA to approve abbreviated new drug applications (ANDAs) for
betamethasone sodium phosphate and betamethasone acetate injection and
betamethasone sodium phosphate injection if all other legal and
regulatory requirements are met. However, in considering whether to
file an ANDA for betamethasone sodium phosphate and betamethasone
acetate injection, future applicants are advised that Celestone
Soluspan injection may not be commercially available because, under a
consent decree between FDA and the manufacturer, it is being made
available in certain instances of medical necessity only. The reasons
for its unavailability are not safety or effectiveness considerations
associated with the drug product in general, but specific to the
manufacturer. An ANDA applicant who is unable to obtain Celestone
Soluspan injection for bioequivalence testing must contact the Office
of Generic Drugs for a determination of what is necessary to show
bioavailability and same therapeutic effect. If the reference listed
drug (RLD) product becomes commercially available prior to ANDA
approval, the ANDA applicant will need to show bioequivalence to the
RLD product.
FOR FURTHER INFORMATION CONTACT: Carol E. Drew, 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 under a new drug
application (NDA). Sponsors of ANDAs do not have to repeat the
extensive clinical testing otherwise necessary to gain approval of an
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 (the 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). Regulations also provide that the
agency must make a determination as to 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 (Sec.
314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an ANDA that
does not refer to a listed drug.
On September 7, 2004, Hikma Farmaceutica (Portugal) LDA submitted
two citizen petitions (Docket Nos. 2004P-0406/CP1 and 2004P-0407/CP1)
to FDA under 21 CFR 10.30 requesting that the agency determine whether
Celestone Soluspan (betamethasone sodium phosphate and betamethasone
acetate) injection equivalent to 6 milligrams (mg) base/milliliter (mL)
(NDA 14-602) and Celestone (betamethasone sodium phosphate) injection
equivalent to 3 mg base/mL (NDA 17-561), both manufactured by Schering-
Plough Corp. (Schering), were withdrawn from sale for reasons of safety
or effectiveness. Celestone Soluspan injection and Celestone injection
are corticosteroids used for their anti-inflammatory effects in
disorders of many organ systems. Schering ceased manufacture of
Celestone injection in March 2004, and it was moved from the
prescription drug product list to the ``Discontinued Drug Product
List'' section of the Orange Book.
[[Page 2048]]
Schering has not discontinued manufacture of Celestone Soluspan
injection; however, as a result of a May 2002 consent decree addressing
manufacturing concerns, Schering's manufacture and distribution of
Celestone Soluspan injection has been limited to providing the drug for
certain medically necessary uses under a limited distribution program.
Celestone Soluspan injection is being distributed as medically
necessary for the following uses: (1) Neonatal use (fetal lung
maturation), (2) epidural route for the management of pain due to
radiculopathy in patients not responsive to systemic drug therapy and
other adjunctive therapies, and (3) intra-articular and soft tissue
injections for synovitis of osteoarthritis, acute gouty arthritis,
nonspecific tenosynovitis, and acute and subacute bursitis. Information
regarding the current distribution for Celestone Soluspan injection by
Schering can be found on FDA's Drug Shortage Web site: https://
www.fda.gov/cder/drug/shortages/celestone.htm.
FDA has reviewed its records and, under Sec. 314.161, has
determined that Celestone Soluspan (betamethasone sodium phosphate and
betamethasone acetate) injection and Celestone (betamethasone sodium
phosphate) injection were not withdrawn from sale for reasons of safety
or effectiveness. Accordingly, the agency will continue to list
betamethasone sodium phosphate 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 betamethasone sodium phosphate may
be approved by the agency. ANDAs that refer to betamethasone sodium
phosphate and betamethasone acetate injection also may be approved by
the agency; however, FDA recommends that in considering whether to file
an ANDA for this drug product, future applicants be advised that the
RLD may not be commercially available because it is being made
available in certain instances of medical necessity only. An ANDA
applicant who is unable to obtain Celestone Soluspan injection for
bioequivalence testing must contact the Office of Generic Drugs for a
determination of what showing is necessary to satisfy the requirements
of section 505(j)(2)(A)(iv) of the act. If an ANDA is approved without
a showing of bioequivalence, the approved product will not be granted
an AB rating in the Orange Book. Future applicants for betamethasone
sodium phosphate and betamethasone acetate injection are advised that
if the RLD product becomes commercially available prior to ANDA
approval, the ANDA applicant will need to show bioequivalence to the
RLD product.
Dated: January 4, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-178 Filed 1-11-06; 8:45 am]
BILLING CODE 4160-01-S
