Determination That CENESTIN (Estrogens, Conjugated Synthetic A) Tablets, 0.3 Milligrams, 0.45 Milligrams, 0.625 Milligrams, 0.9 Milligrams, and 1.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 41273-41274 [2017-18376]
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mstockstill on DSK30JT082PROD with NOTICES
Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: October
26, 2009. FDA has verified the
applicant’s claim that the date the
investigational new drug application
became effective was on October 26,
2009.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: April 25, 2014.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
XTORO (NDA 206307) was initially
submitted on April 25, 2014.
3. The date the application was
approved: December 17, 2014. FDA has
verified the applicant’s claim that NDA
206307 was approved on December 17,
2014.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,058 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in 21 CFR
60.30, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of 21
CFR 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with 21 CFR 10.20,
must contain sufficient facts to merit an
FDA investigation, and must certify that
a true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
VerDate Sep<11>2014
17:40 Aug 29, 2017
Jkt 241001
Dated: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18379 Filed 8–29–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0002]
Upsher-Smith Laboratories, Inc.;
Withdrawal of Approval of an
Abbreviated New Drug Application for
PROPRANOLOL HYDROCHLORIDE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
withdrawing approval of an abbreviated
new drug application (ANDA) for
PROPRANOLOL HYDROCHLORIDE
Extended-Release Capsules, held by
Upsher-Smith Laboratories, Inc.
(Upsher-Smith), 6701 Evenstad Dr.,
Maple Grove, MN 55369. Upsher-Smith
has voluntarily requested that approval
of this application be withdrawn and
has waived its opportunity for a hearing.
DATES: August 30, 2017.
FOR FURTHER INFORMATION CONTACT:
Stefanie Kraus, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6215,
Silver Spring, MD 20993–0002, 301–
796–9585.
SUPPLEMENTARY INFORMATION: On March
6, 2009, FDA approved abbreviated new
drug application (ANDA) 078311 for
PROPRANOLOL HYDROCHLORIDE
Extended-Release Capsules, USP, 60
milligrams (mg), 80 mg, 120 mg, and
160 mg. In a letter dated August 9, 2011,
FDA informed Upsher-Smith that it had
concerns about the validity of
bioequivalence data submitted with
ANDA 078311 from studies conducted
by a certain contract research
organization, establishing
bioequivalence of Upsher-Smith’s
product to the reference listed drug
(RLD), INDERAL LA (propranolol
hydrochloride) Extended Release
Capsules, 60 mg, 80 mg, 120 mg, and
160 mg. In that letter, FDA directed
Upsher-Smith to supplement its ANDA
with either: (1) New bioequivalence
studies or (2) re-assays of the samples
from the original bioequivalence
studies. Upsher-Smith submitted new
fasted and fed bioequivalence studies to
SUMMARY:
PO 00000
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41273
supplement ANDA 078311 in paper
format on August 29, 2013, and in
electronic format on May 9, 2014.
On April 14, 2016, FDA informed
Upsher-Smith that the applicant’s fed
bioequivalence study failed to meet
FDA’s bioequivalence criteria and,
therefore, requested that Upsher-Smith
voluntarily seek withdrawal of ANDA
078311 under § 314.150(d) (21 CFR
314.150(d)).
In a letter dated May 13, 2016,
Upsher-Smith requested that FDA
withdraw approval of ANDA 078311 for
PROPRANOLOL HYDROCHLORIDE
Extended-Release Capsules under
§ 314.150(d) because the new
bioequivalence data did not
demonstrate therapeutic equivalence of
its product to the RLD, INDERAL LA. In
that letter, Upsher-Smith also waived
any opportunity for a hearing otherwise
provided under § 314.150(a).
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(e)) and
§ 314.150(d), and under authority
delegated by the Commissioner of Food
and Drugs to the Director, Center for
Drug Evaluation and Research, approval
of ANDA 078311, and all amendments
and supplements thereto, is withdrawn
(see DATES). Distribution of this product
in interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the FD&C Act (21
U.S.C. 355(a) and 331(d)).
Dated: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18375 Filed 8–29–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–1461]
Determination That CENESTIN
(Estrogens, Conjugated Synthetic A)
Tablets, 0.3 Milligrams, 0.45 Milligrams,
0.625 Milligrams, 0.9 Milligrams, and
1.25 Milligrams, Were Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that CENESTIN (estrogens,
conjugated synthetic A) Tablets, 0.3
milligrams (mg), 0.45 mg, 0.625 mg, 0.9
SUMMARY:
E:\FR\FM\30AUN1.SGM
30AUN1
mstockstill on DSK30JT082PROD with NOTICES
41274
Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices
mg, and 1.25 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 these
products, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Bronwen Blass, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6228,
Silver Spring, MD 20993–0002, 301–
796–5092.
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 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.
CENESTIN (estrogens, conjugated
synthetic A) Tablets, 0.3 mg, 0.45 mg,
0.625 mg, 0.9 mg, and 1.25 mg, is the
subject of NDA 020992, held by Teva
Branded Pharmaceutical Products R&D,
Inc. (Teva), and was initially approved
VerDate Sep<11>2014
17:40 Aug 29, 2017
Jkt 241001
on March 24, 1999. CENESTIN is
indicated for treatment of moderate to
severe vasomotor symptoms due to
menopause and treatment of moderate
to severe symptoms of vulvar and
vaginal atrophy due to menopause.
In 2016, Teva notified FDA that
CENESTIN (estrogens, conjugated
synthetic A) Tablets, 0.3 mg, 0.45 mg,
0.625 mg, 0.9 mg, and 1.25 mg, were
being discontinued, and FDA moved the
drug product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Foley & Lardner submitted a citizen
petition dated March 8, 2017 (Docket
No. FDA–2017–P–1461), under 21 CFR
10.30, requesting that the Agency
determine whether CENESTIN
(estrogens, conjugated synthetic A)
Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9
mg, and 1.25 mg, were withdrawn from
sale for reasons of safety or
effectiveness.
After considering the citizen and
reviewing Agency records and based on
the information we have at this time,
FDA has determined under § 314.161
that CENESTIN (estrogens, conjugated
synthetic A) Tablets, 0.3 mg, 0.45 mg,
0.625 mg, 0.9 mg, and 1.25 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that these products were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of these
products 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 drug products were
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list CENESTIN (estrogens,
conjugated synthetic A) Tablets, 0.3 mg,
0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg,
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 CENESTIN (estrogens, conjugated
synthetic A) Tablets, 0.3 mg, 0.45 mg,
0.625 mg, 0.9 mg, and 1.25 mg, 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.
PO 00000
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Fmt 4703
Sfmt 4703
Dated: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18376 Filed 8–29–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2016–E–1283; FDA–
2016–E–1291]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; KENGREAL
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for KENGREAL and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by October 30, 2017.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
February 26, 2018. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 30,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 30, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\30AUN1.SGM
30AUN1
]]>Agencies
[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Pages 41273-41274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18376]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-P-1461]
Determination That CENESTIN (Estrogens, Conjugated Synthetic A)
Tablets, 0.3 Milligrams, 0.45 Milligrams, 0.625 Milligrams, 0.9
Milligrams, and 1.25 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 or Agency) has
determined that CENESTIN (estrogens, conjugated synthetic A) Tablets,
0.3 milligrams (mg), 0.45 mg, 0.625 mg, 0.9
[[Page 41274]]
mg, and 1.25 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 these products, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Bronwen Blass, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-
796-5092.
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 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.
CENESTIN (estrogens, conjugated synthetic A) Tablets, 0.3 mg, 0.45
mg, 0.625 mg, 0.9 mg, and 1.25 mg, is the subject of NDA 020992, held
by Teva Branded Pharmaceutical Products R&D, Inc. (Teva), and was
initially approved on March 24, 1999. CENESTIN is indicated for
treatment of moderate to severe vasomotor symptoms due to menopause and
treatment of moderate to severe symptoms of vulvar and vaginal atrophy
due to menopause.
In 2016, Teva notified FDA that CENESTIN (estrogens, conjugated
synthetic A) Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg,
were being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Foley & Lardner submitted a citizen petition dated March 8, 2017
(Docket No. FDA-2017-P-1461), under 21 CFR 10.30, requesting that the
Agency determine whether CENESTIN (estrogens, conjugated synthetic A)
Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, were withdrawn
from sale for reasons of safety or effectiveness.
After considering the citizen and reviewing Agency records and
based on the information we have at this time, FDA has determined under
Sec. 314.161 that CENESTIN (estrogens, conjugated synthetic A)
Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, were not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that these products
were withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
these products 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 drug products were
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list CENESTIN (estrogens,
conjugated synthetic A) Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and
1.25 mg, 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
CENESTIN (estrogens, conjugated synthetic A) Tablets, 0.3 mg, 0.45 mg,
0.625 mg, 0.9 mg, and 1.25 mg, 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: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18376 Filed 8-29-17; 8:45 am]
BILLING CODE 4164-01-P
