Determination That PHENERGAN (Promethazine Hydrochloride) Tablets, 12.5 Milligrams and 50 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 40129-40130 [E6-11072]
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Federal Register / Vol. 71, No. 135 / Friday, July 14, 2006 / Notices
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1976), and last amended at 70 FR 34186
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jlentini on PROD1PC65 with NOTICES
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[FR Doc. 06–6226 Filed 7–13–06; 8:45 am]
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17:44 Jul 13, 2006
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2005P–0300 and 2005P–0319]
Determination That PHENERGAN
(Promethazine Hydrochloride) Tablets,
12.5 Milligrams and 50 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Were Not Withdrawn From Sale for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 PHENERGAN (promethazine
hydrochloride (HCl)) tablets, 12.5
milligrams (mg) and 50 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withdrawn from sale for reasons of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 promethazine
HCl tablets, 12.5 mg and 50 mg.
FOR FURTHER INFORMATION CONTACT:
Quynh Nguyen, 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 (the 1984
amendments) (Public Law 98–417),
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
SUPPLEMENTARY INFORMATION:
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40129
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.
PHENERGAN (promethazine HCl)
tablets, 12.5 mg and 50 mg, are the
subject of approved NDA 7–935 held by
Wyeth Pharmaceuticals, Inc. (Wyeth).
PHENERGAN (promethazine HCl)
tablets are indicated for, among other
things, certain types of allergic reactions
and sedation. Wyeth’s NDA 7–935 was
originally approved in 1951. In 1971,
under the Drug Efficacy Study
Implementation (DESI), FDA concluded
that promethazine HCl tablets were
effective or probably effective for the
indications described in the Federal
Register notice published on June 18,
1971 (DESI 6290, 36 FR 11758). Wyeth
discontinued sale of the 12.5 mg and 50
mg tablets in 2004. Amide
Pharmaceutical, Inc., and Peter S.
Reichertz submitted citizen petitions
dated July 28, 2005 (Docket No. 2005P–
0300/CP1), and August 10, 2005 (Docket
No. 2005P–0319/CP1), respectively,
under 21 CFR 10.30, requesting that the
agency determine, as described in
§ 314.161, whether PHENERGAN
(promethazine HCl) tablets, 12.5 mg and
50 mg, were withdrawn from sale for
reasons of safety or effectiveness.
The agency has determined that
Wyeth’s PHENERGAN (promethazine
HCl) tablets, 12.5 mg and 50 mg, were
not withdrawn from sale for reasons of
safety or effectiveness. In support of this
finding, we note that promethazine HCl
is a widely used product that has been
marketed for many decades in many
dosage forms. FDA has independently
evaluated relevant literature and data
for adverse event reports and has found
no information that would indicate that
PHENERGAN tablets, 12.5 mg and 50
mg, were withdrawn for reasons of
safety or effectiveness.
After considering the citizen petitions
(including comments submitted) and
reviewing agency records, FDA
determines that for the reasons outlined
previously, Wyeth’s PHENERGAN
(promethazine HCl) tablets, 12.5 mg and
50 mg, were not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the agency will continue
to list PHENERGAN (promethazine HCl)
tablets, 12.5 mg and 50 mg, in the
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40130
Federal Register / Vol. 71, No. 135 / Friday, July 14, 2006 / Notices
‘‘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 PHENERGAN (promethazine HCl)
tablets, 12.5 mg and 50 mg, may be
approved by the agency as long as they
meet all relevant legal and regulatory
requirements for the approval of
ANDAs.
Dated: June 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–11072 Filed 7–13–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0266]
Medical Devices; Anesthesiology
Devices; Neurological Devices; Denial
of Request for Change in Classification
of Breathing Frequency Monitor and
Electroencephalograph
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; denial of petition.
SUMMARY: The Food and Drug
Administration (FDA) is denying the
petitions submitted by IM Systems to
reclassify the SleepCheck, the ActiTrac,
and PAM–RL devices from class II
(special controls) to class I (general
controls). The agency is denying the
petitions because the petitioner failed to
provide sufficient new information to
establish that general controls would
provide reasonable assurance of the
safety and effectiveness of the devices.
FOR FURTHER INFORMATION CONTACT:
Heather S. Rosecrans, Center for Devices
and Radiological Health (HFZ–404),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
301–594–1190.
SUPPLEMENTARY INFORMATION:
jlentini on PROD1PC65 with NOTICES
I. Classification and Reclassification of
Devices Under the Medical Devices
Amendments of 1976 (the 1976
Amendments)
The Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 301 et seq.), as
amended by the 1976 amendments
(Public Law 94–295), the Safe Medical
Devices Act of 1990 (SMDA) (Public
Law 101–629), and the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Public Law 105–115)
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established a comprehensive system for
the regulation of medical devices
intended for human use. Section 513 of
the act (21 U.S.C. 360c) established
three categories (classes) of devices,
depending on the regulatory controls
needed to provide reasonable assurance
of their safety and effectiveness. The
three categories of devices under the
1976 amendments are class I (general
controls), class II (special controls), and
class III (premarket approval).
Under section 513 of the act, devices
that were in commercial distribution
before May 28, 1976 (the date of
enactment of the amendments),
generally referred to as preamendments
devices, are classified after FDA has: (1)
Received a recommendation from a
device classification panel (an FDA
advisory committee); (2) published the
panel’s recommendation for comment,
along with a proposed regulation
classifying the device; and (3) published
a final regulation classifying the device.
FDA has classified most preamendment
devices under these procedures.
Devices that were not in commercial
distribution prior to May 28, 1976,
generally referred to as postamendments
devices, are classified automatically by
statute (section 513(f) of the act) into
class III without any FDA rulemaking
process. Postamendments devices
remain in class III and require
premarket approval, unless: (1) The
device is reclassified into class I or II;
(2) FDA issues an order classifying the
device into class I or II in accordance
with section 513(f)(2) of the act; or (3)
FDA issues an order finding the device
to be substantially equivalent, under
section 513(i) of the act, to a predicate
device that does not require premarket
approval. The agency determines
whether new devices are substantially
equivalent to predicate marketed
devices by means of premarket
notification procedures in section 510(k)
of the act (21 U.S.C. 360(k)) and 21 CFR
part 807, subpart E of the regulations.
Reclassification of classified
preamendments devices is governed by
section 513(e) of the act. This section of
the act provides that FDA may, by
rulemaking, reclassify a device based on
‘‘new information.’’ The reclassification
can be initiated by FDA or by the
petition of an interested person. The
term ‘‘new information,’’ as used in
section 513(e) of the act includes
information developed as a result of a
reevaluation of the data before the
agency when the device was originally
classified, as well as information not
presented, not available, or not
developed at that time. (See, e.g.,
Holland Rantos v. United States
Department of Health, Education, and
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Welfare, 587 F.2d 1173, 1174 n.1 (D.C.
Cir. 1978); Upjohn v. Finch, 422 F.2d
944 (6th Cir. 1970); Bell v. Goddard, 366
F.2d 177 (7th Cir. 1966).)
Reevaluation of the data previously
before the agency is an appropriate basis
for subsequent regulatory action where
the reevaluation is made in light of
newly available regulatory authority
(see Bell v. Goddard, supra, 366 F.2d at
181; Ethicon, Inc. v. FDA, 762 F.Supp.
382, 389–91 (D.D.C. 1991)), or in light
of changes in ‘‘medical science.’’ (See
Upjohn v. Finch, supra, 422 F.2d at
951.).
Regardless of whether data before the
agency are past or new data, the ‘‘new
information’’ upon which
reclassification under section 513(e) of
the act is based must consist of ‘‘valid
scientific evidence,’’ as defined in
section 513(a)(3) of the act and
§ 860.7(c)(2) (21 CFR 860.7(c)(2)). (See,
e.g., General Medical Co. v. FDA, 770
F.2d 214 (D.C. Cir. 1985); Contact Lens
Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.),
cert. denied, 474 U.S. 1062 (1985)). In
addition, § 860.123(a)(6) (21 CFR
860.123(a)(6)) provides that a
reclassification petition must include a
‘‘full statement of the reasons, together
with supporting data satisfying the
requirements of § 860.7, why the device
should not be classified into its present
classification and how the proposed
classification will provide reasonable
assurance of the safety and effectiveness
of the device.’’ (§ 860.123(a)(6).) The
‘‘supporting data satisfying the
requirements of § 860.7’’ referred to is
‘‘valid scientific evidence.’’
For the purpose of reclassification, the
valid scientific evidence upon which
the agency relies must be publicly
available. Publicly available information
excludes trade secret and/or
confidential commercial information,
e.g., the contents of a pending PMA.
(See section 520(c) of the act (21 U.S.C.
360j(c).)
II. Reclassification Under the SMDA
SMDA further amended the act to
change the definition of a class II
device. Under the SMDA, class II
devices are those devices that cannot be
classified into class I because general
controls by themselves are not sufficient
to provide reasonable assurance of
safety and effectiveness, but for which
there is sufficient information to
establish special controls to provide
such assurance, including performance
standards, postmarket surveillance,
patient registries, development and
dissemination of guidelines,
recommendations, and other
appropriate actions the agency deems
necessary (Section 513(a)(1)(B) of the
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]]>Agencies
[Federal Register Volume 71, Number 135 (Friday, July 14, 2006)]
[Notices]
[Pages 40129-40130]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11072]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2005P-0300 and 2005P-0319]
Determination That PHENERGAN (Promethazine Hydrochloride)
Tablets, 12.5 Milligrams and 50 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
PHENERGAN (promethazine hydrochloride (HCl)) tablets, 12.5 milligrams
(mg) and 50 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 promethazine HCl tablets, 12.5 mg and
50 mg.
FOR FURTHER INFORMATION CONTACT: Quynh Nguyen, 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 (the 1984
amendments) (Public Law 98-417), 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.
PHENERGAN (promethazine HCl) tablets, 12.5 mg and 50 mg, are the
subject of approved NDA 7-935 held by Wyeth Pharmaceuticals, Inc.
(Wyeth). PHENERGAN (promethazine HCl) tablets are indicated for, among
other things, certain types of allergic reactions and sedation. Wyeth's
NDA 7-935 was originally approved in 1951. In 1971, under the Drug
Efficacy Study Implementation (DESI), FDA concluded that promethazine
HCl tablets were effective or probably effective for the indications
described in the Federal Register notice published on June 18, 1971
(DESI 6290, 36 FR 11758). Wyeth discontinued sale of the 12.5 mg and 50
mg tablets in 2004. Amide Pharmaceutical, Inc., and Peter S. Reichertz
submitted citizen petitions dated July 28, 2005 (Docket No. 2005P-0300/
CP1), and August 10, 2005 (Docket No. 2005P-0319/CP1), respectively,
under 21 CFR 10.30, requesting that the agency determine, as described
in Sec. 314.161, whether PHENERGAN (promethazine HCl) tablets, 12.5 mg
and 50 mg, were withdrawn from sale for reasons of safety or
effectiveness.
The agency has determined that Wyeth's PHENERGAN (promethazine HCl)
tablets, 12.5 mg and 50 mg, were not withdrawn from sale for reasons of
safety or effectiveness. In support of this finding, we note that
promethazine HCl is a widely used product that has been marketed for
many decades in many dosage forms. FDA has independently evaluated
relevant literature and data for adverse event reports and has found no
information that would indicate that PHENERGAN tablets, 12.5 mg and 50
mg, were withdrawn for reasons of safety or effectiveness.
After considering the citizen petitions (including comments
submitted) and reviewing agency records, FDA determines that for the
reasons outlined previously, Wyeth's PHENERGAN (promethazine HCl)
tablets, 12.5 mg and 50 mg, were not withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the agency will continue to list
PHENERGAN (promethazine HCl) tablets, 12.5 mg and 50 mg, in the
[[Page 40130]]
``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 PHENERGAN
(promethazine HCl) tablets, 12.5 mg and 50 mg, may be approved by the
agency as long as they meet all relevant legal and regulatory
requirements for the approval of ANDAs.
Dated: June 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11072 Filed 7-13-06; 8:45 am]
BILLING CODE 4160-01-S
