Determination That PYRIDOSTIGMINE BROMIDE Tablets, 30 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 35683-35684 [05-12108]
Download as PDF
<![CDATA[
35683
Federal Register / Vol. 70, No. 118 / Tuesday, June 21, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of Respondents
606.170(b)2
610.40(c)(1)(ii)
610.40(g)(2)
610.40(h)(2)(ii)(A)
610.40(h)(2)(ii)(C) and (h)(2)(ii)(D)
610.40(h)(2)(vi)
610.42(a)
610.46(a)
610.46(b)
610.47(b)
630.6(a)3
630.6(a)4
630.6(d)(1)
Total
Annual Frequency per
Response
82
1,628
1
1
40
1,628
1
1,709
1,709
134
570
85
81
Total Annual
Responses
1
8
1
1
12
11
1
16
16
1
760
106
37
Hours per Response
82
12,000
1
1
480
18,000
1
26,544
26,544
134
433,333
9,000
3,000
Total Hours
20
0.08
1
1
0.2
0.08
1
0.17
0.17
1
0.08
1.5
1
1,640
960
1
1
96
1,440
1
4,512
4,512
134
34,667
13,500
3,000
64,464
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
reporting requirement in § 640.73, which addresses the reporting of fatal donor reactions, is included in the estimate for § 606.170(b).
3Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria.
4Notification of donors deferred based on reactive test results for evidence of infection due to communicable disease agents.
2The
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of Recordkeepers
Annual Frequency per
Recordkeeping
Total Annual Records
2495
2495
396
2495
2495
1,709
1,628
2495
2495
1,628
1
10
1
12
1,928
1,024
4
1,928
12
1
249
2,490
39
2,988
480,000
1,750,000
6,750
480,000
2,988
1,628
606.100(b)2
606.100(c)
606.110(a)3
606.151(e)
606.1604
606.160(b)(1)(ix)
606.160(b)(1)(xi)
606.165
606.170(a)
610.40(g)(1)
Total
Hours per Record
Total Hours
24
1
0.5
0.083
0.75
0.05
0.05
0.083
1
0.5
5,976
2,490
20
248
360,000
87,500
338
39,840
2,988
814
500, 214
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
recordkeeping requirements in §§ 640.3(a)(1), 640.4(a)(1), and 640.66, which address the maintenance of SOPs, are included in the estimate for § 606.100(b).
3The recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included
in the estimate for § 606.110(a).
4The recordkeeping requirements in §§ 640.3(a)(2) and (f); 640.4(a)(2); 640.25(b)(4) and (c)(1); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and
(c); 640.56(b) and (d); 640.61; 640.63(b)(3), (e)(1), and (e)(3); 640.65(b)(2); 640.71(b)(1); 640.72; and 640.76(a) and (b), which address the
maintenance of various records are included in the estimate for § 606.160.
5Five percent of CMS transfusion services and FDA-registered blood establishments (0.05 X 4,980).
6Five percent of plateletpheresis and leukopheresis establishments (0.05 X 773).
2The
Dated: June 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–12180 Filed 6–20–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003P–0501]
Determination That PYRIDOSTIGMINE
BROMIDE Tablets, 30 Milligrams, Were
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
VerDate jul<14>2003
22:07 Jun 20, 2005
Jkt 205001
ACTION:
Notice.
Lane, Rockville, MD 20857, 301–443–
5535.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that PYRIDOSTIGMINE BROMIDE
tablets, 30 milligrams (mg), for the
treatment of myasthenia gravis, were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for
PYRIDOSTIGMINE BROMIDE tablets,
30 mg, for the treatment of myasthenia
gravis.
S.
Mitchell Weitzman, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
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 typically 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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\21JNN1.SGM
21JNN1
35684
Federal Register / Vol. 70, No. 118 / Tuesday, June 21, 2005 / Notices
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
in part 314 (21 CFR part 314), 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 (§ 314.162).
Under § 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.
PYRIDOSTIGMINE BROMIDE
(mestinon) tablets (NDA 009–829), 60
mg, were originally approved on April
6, 1955, to treat myasthenia gravis. They
were deemed effective under the Drug
Efficacy Study Implementation on
November 4, 1970 (35 FR 16992).
A suitability petition was submitted
under section 355(j)(2)(C) of the act and
was approved for a change in strength
for PYRIDOSTIGMINE BROMIDE
(mestinon) tablets (i.e., from 60-mg
tablets to 30-mg tablets) for the
treatment of myasthenia gravis (see
January 22, 1986, letter; Docket No.
1985P–0412). FDA approved ANDA 89–
572, held by Solvay Pharmaceuticals,
Inc., (Solvay), on November 27, 1990,
for PYRIDOSTIGMINE BROMIDE
tablets, 30 mg, for the treatment of
myasthenia gravis. Solvay’s
PYRIDOSTIGMINE BROMIDE tablets,
30 mg, were discontinued from
marketing on May 12, 1994, and at
Solvay’s request, approval of ANDA 89–
572 was withdrawn effective August 11,
1994 (59 FR 35527, July 12, 1994).
On October 29, 2003, Lachman
Consultant Services, Inc., submitted a
citizen petition (Docket No. 2003P–
0501) under 21 CFR 10.30 requesting
that the agency determine whether
PYRIDOSTIGMINE BROMIDE tablets,
30 mg, for the treatment of myasthenia
gravis, were withdrawn from sale for
reasons of safety or effectiveness.
The agency has determined that
PYRIDOSTIGMINE BROMIDE tablets,
VerDate jul<14>2003
22:07 Jun 20, 2005
Jkt 205001
30 mg, for the treatment of myasthenia
gravis, were not withdrawn from sale for
reasons of safety or effectiveness. The
original basis for approving the
suitability petition has not changed.
PYRIDOSTIGMINE BROMIDE
(mestinon) tablets, 60 mg, currently
appear in the active section of the
Orange Book. The agency notes that
PYRIDOSTIGMINE BROMIDE
(mestinon) tablets, 60 mg, are still being
marketed by several other
manufacturers (e.g., Impax Labs,
Corepharma, and Barr).
PYRIDOSTIGMINE BROMIDE
(mestinon) syrup (NDA 15–193), 60 mg/
5 milliliters, also appears in the active
section of the Orange Book. In
approving the suitability petition, the
agency noted that:
[a]lthough the proposed strength is less
than the currently approved product, the
labeling of the currently approved products
indicates that doses of 30 mg or even less
may be utilized. Additionally, incremental
doses are encouraged in approved labeling,
especially ‘‘for children and brittle
myasthenic patients who require fractions of
60-mg doses’’
(see Docket No. 1985P–0412). The
currently available, relevant information
does not call into question the agency’s
January 22, 1986, determination that
ANDAs for PYRIDOSTIGMINE
BROMIDE tablets, 30 mg, for the
treatment of myasthenia gravis, are
suitable for submission.
The agency notes that
PYRIDOSTIGMINE BROMIDE tablets,
30 mg, are also indicated for
prophylaxis against the lethal effects of
soman nerve agent poisoning, and are
the subject of NDA 20–414. The U.S.
Army submitted NDA 20–414, which
was approved on February 5, 2003,
under subpart I of the new drug
regulations (§§ 314.600 through
314.650). NDA 20–414 is displayed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book. Drug
products approved for the U.S. Army
are displayed in the discontinued
section of the Orange Book because they
are not commercially available. The
agency notes that NDA 20–414 is not the
subject of this determination. The issue
here is whether PYRIDOSTIGMINE
BROMIDE tablets, 30 mg, for the
treatment of myasthenia gravis (i.e.,
ANDA 89–572), were withdrawn from
sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing agency records, FDA
determines that, for the reasons stated in
this document, PYRIDOSTIGMINE
BROMIDE tablets, 30 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
agency will continue to list
PYRIDOSTIGMINE BROMIDE tablets,
30 mg, for the treatment of myasthenia
gravis, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. ANDAs that refer to
PYRIDOSTIGMINE BROMIDE tablets,
30 mg, for the treatment of myasthenia
gravis, may be approved by the agency.
Dated: June 14, 2005.
Jeffrey Shruen,
Assistant Commissioner for Policy.
[FR Doc. 05–12108 Filed 6–20–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0227]
Update on Leukocyte Reduction of
Blood and Blood Components; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Update on Leukocyte
Reduction of Blood and Blood
Components.’’ The public workshop
sponsors are FDA; the National
Institutes of Health (NIH) National
Heart, Lung, and Blood Institute
(NHLBI); and the Office of Public Health
and Science (OPHS) in the Department
of Health and Human Services. The
purpose of the public workshop is to
address current issues related to
leukocyte-reduced blood and blood
components.
Date and Time: The public workshop
will be held on July 20, 2005, from 8
a.m. to 5:30 p.m.
Location: The public workshop will
be held at the National Institutes of
Health, Lister Hill Center Auditorium,
Bldg. 38A, 8600 Rockville Pike,
Bethesda, MD 20894.
Contact: Rhonda Dawson, Center for
Biologics Evaluation and Research
(HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448, 301–827–
3514, FAX: 301–827–2843, e-mail:
dawsonr@cber.fda.gov.
Registration: Send registration
information (including name, title, firm
name, address, telephone, and fax
number) to Rhonda Dawson (see
Contact) by July 1, 2005. Because
seating is limited, we recommend early
registration. Registration at the site on
the day of the public workshop will be
E:\FR\FM\21JNN1.SGM
21JNN1
]]>Agencies
[Federal Register Volume 70, Number 118 (Tuesday, June 21, 2005)]
[Notices]
[Pages 35683-35684]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12108]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003P-0501]
Determination That PYRIDOSTIGMINE BROMIDE Tablets, 30 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
PYRIDOSTIGMINE BROMIDE tablets, 30 milligrams (mg), for the treatment
of myasthenia gravis, were not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for PYRIDOSTIGMINE BROMIDE
tablets, 30 mg, for the treatment of myasthenia gravis.
FOR FURTHER INFORMATION CONTACT: S. Mitchell Weitzman, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5535.
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
typically 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
[[Page 35684]]
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 in part 314 (21 CFR part 314),
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 (Sec. 314.162).
Under Sec. 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.
PYRIDOSTIGMINE BROMIDE (mestinon) tablets (NDA 009-829), 60 mg,
were originally approved on April 6, 1955, to treat myasthenia gravis.
They were deemed effective under the Drug Efficacy Study Implementation
on November 4, 1970 (35 FR 16992).
A suitability petition was submitted under section 355(j)(2)(C) of
the act and was approved for a change in strength for PYRIDOSTIGMINE
BROMIDE (mestinon) tablets (i.e., from 60-mg tablets to 30-mg tablets)
for the treatment of myasthenia gravis (see January 22, 1986, letter;
Docket No. 1985P-0412). FDA approved ANDA 89-572, held by Solvay
Pharmaceuticals, Inc., (Solvay), on November 27, 1990, for
PYRIDOSTIGMINE BROMIDE tablets, 30 mg, for the treatment of myasthenia
gravis. Solvay's PYRIDOSTIGMINE BROMIDE tablets, 30 mg, were
discontinued from marketing on May 12, 1994, and at Solvay's request,
approval of ANDA 89-572 was withdrawn effective August 11, 1994 (59 FR
35527, July 12, 1994).
On October 29, 2003, Lachman Consultant Services, Inc., submitted a
citizen petition (Docket No. 2003P-0501) under 21 CFR 10.30 requesting
that the agency determine whether PYRIDOSTIGMINE BROMIDE tablets, 30
mg, for the treatment of myasthenia gravis, were withdrawn from sale
for reasons of safety or effectiveness.
The agency has determined that PYRIDOSTIGMINE BROMIDE tablets, 30
mg, for the treatment of myasthenia gravis, were not withdrawn from
sale for reasons of safety or effectiveness. The original basis for
approving the suitability petition has not changed. PYRIDOSTIGMINE
BROMIDE (mestinon) tablets, 60 mg, currently appear in the active
section of the Orange Book. The agency notes that PYRIDOSTIGMINE
BROMIDE (mestinon) tablets, 60 mg, are still being marketed by several
other manufacturers (e.g., Impax Labs, Corepharma, and Barr).
PYRIDOSTIGMINE BROMIDE (mestinon) syrup (NDA 15-193), 60 mg/5
milliliters, also appears in the active section of the Orange Book. In
approving the suitability petition, the agency noted that:
[a]lthough the proposed strength is less than the currently
approved product, the labeling of the currently approved products
indicates that doses of 30 mg or even less may be utilized.
Additionally, incremental doses are encouraged in approved labeling,
especially ``for children and brittle myasthenic patients who
require fractions of 60-mg doses''
(see Docket No. 1985P-0412). The currently available, relevant
information does not call into question the agency's January 22, 1986,
determination that ANDAs for PYRIDOSTIGMINE BROMIDE tablets, 30 mg, for
the treatment of myasthenia gravis, are suitable for submission.
The agency notes that PYRIDOSTIGMINE BROMIDE tablets, 30 mg, are
also indicated for prophylaxis against the lethal effects of soman
nerve agent poisoning, and are the subject of NDA 20-414. The U.S. Army
submitted NDA 20-414, which was approved on February 5, 2003, under
subpart I of the new drug regulations (Sec. Sec. 314.600 through
314.650). NDA 20-414 is displayed in the ``Discontinued Drug Product
List'' section of the Orange Book. Drug products approved for the U.S.
Army are displayed in the discontinued section of the Orange Book
because they are not commercially available. The agency notes that NDA
20-414 is not the subject of this determination. The issue here is
whether PYRIDOSTIGMINE BROMIDE tablets, 30 mg, for the treatment of
myasthenia gravis (i.e., ANDA 89-572), were withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition and reviewing agency
records, FDA determines that, for the reasons stated in this document,
PYRIDOSTIGMINE BROMIDE tablets, 30 mg, were not withdrawn from sale for
reasons of safety or effectiveness. Accordingly, the agency will
continue to list PYRIDOSTIGMINE BROMIDE tablets, 30 mg, for the
treatment of myasthenia gravis, in the ``Discontinued Drug Product
List'' section of the Orange Book. ANDAs that refer to PYRIDOSTIGMINE
BROMIDE tablets, 30 mg, for the treatment of myasthenia gravis, may be
approved by the agency.
Dated: June 14, 2005.
Jeffrey Shruen,
Assistant Commissioner for Policy.
[FR Doc. 05-12108 Filed 6-20-05; 8:45 am]
BILLING CODE 4160-01-S
