Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for PROPRANOLOL HYDROCHLORIDE, 41273 [2017-18375]
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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
]]>Agencies
[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Page 41273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18375]
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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.
-----------------------------------------------------------------------
SUMMARY: 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 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 Sec. 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 Sec. 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 Sec.
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 Sec. 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
