InvaGen Pharmaceuticals, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for Trandolapril Tablets, 41998-41999 [2020-14981]
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41998
Federal Register / Vol. 85, No. 134 / Monday, July 13, 2020 / Notices
May 13, 2019, FDA advised the USPTO
that this human drug product had
undergone a regulatory review period
and that the approval of XEPI
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
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II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
XEPI is 2,819 days. Of this time, 2,282
days occurred during the testing phase
of the regulatory review period, while
537 days occurred during the 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 (FD&C Act) (21 U.S.C.
355(i)) became effective: March 26,
2010. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was March 26, 2010.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: June 23, 2016.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
XEPI (NDA 208945) was initially
submitted on June 23, 2016.
3. The date the application was
approved: December 11, 2017. FDA has
verified the applicant’s claim that NDA
208945 was approved on December 11,
2017.
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 1,678 days of patent
term extension.
III. Petitions
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 § 60.30 (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
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
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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.
Dated: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–15013 Filed 7–10–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3708]
InvaGen Pharmaceuticals, Inc.;
Withdrawal of Approval of an
Abbreviated New Drug Application for
Trandolapril Tablets
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is withdrawing approval of an
abbreviated new drug application
(ANDA) for trandolapril tablets. The
basis for the withdrawal is that the
holder of the ANDA has repeatedly
failed to submit the required data to
support a finding of bioequivalence for
this ANDA. The holder of the ANDA
has waived its opportunity for a hearing.
DATES: Withdrawal of approval is
applicable July 13, 2020.
FOR FURTHER INFORMATION CONTACT:
Jennifer Forde, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228,
Silver Spring, MD 20993–0002, 301–
348–3035.
SUPPLEMENTARY INFORMATION: FDA’s
Office of Generic Drugs (OGD) approved
ANDA 078320, held by InvaGen
Pharmaceuticals, Inc. (InvaGen), for a
generic version of trandolapril tablets, 1
milligram (mg), 2 mg, and 4 mg, under
the requirements of section 505(j) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(j)) and FDA’s
implementing regulations. OGD
SUMMARY:
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approved ANDA 078320 on June 12,
2007. In a notice published in the
Federal Register of October 28, 2019 (84
FR 57736), CDER notified InvaGen of
CDER’s proposal to issue an order,
under section 505(e) of the FD&C Act
and § 314.150 (21 CFR 314.150),
withdrawing approval of ANDA 078320
and all amendments and supplements to
it on the grounds that InvaGen has
failed to submit the required
bioequivalence data necessary to
demonstrate the bioequivalence of its
drug product. In its October 28, 2019,
notice of opportunity for a hearing
(NOOH), CDER provided InvaGen with
an opportunity to request a hearing to
show why approval of ANDA 078320
should not be withdrawn.
As noted in the October 28, 2019,
NOOH, FDA issued a letter to InvaGen
on August 9, 2011, regarding ANDA
078320 because this drug product
application was supported by
bioequivalence studies with the
bioanalytical analysis conducted by
Cetero Research at the Houston, TX, site
between April 1, 2005, and June 15,
2010. As FDA noted in its August 9,
2011, correspondence, inspection
findings regarding Cetero Research’s
bioequivalence studies raised significant
concerns about the validity of the
reported results of the analytical studies
conducted between April 2005 and June
2010 in support of drug applications,
and as such, steps needed to be taken to
demonstrate the bioequivalence of
InvaGen’s drug product approved under
ANDA 078320. FDA informed InvaGen
that ANDA 078320 needed to be
supplemented by conducting new
bioequivalence studies or re-assaying
the samples from the original
bioequivalence study. FDA
recommended to InvaGen that the
results of the requested bioequivalence
studies or re-assays be submitted to
ANDA 078320 within 6 months of the
date of the August 9, 2011, letter.
Although the October 28, 2019,
NOOH states that FDA did not receive
a response from InvaGen to the August
9, 2011, letter from FDA, upon further
review, additional correspondence
between InvaGen and FDA has been
identified. In a letter to FDA dated
August 12, 2011, InvaGen requested a 6month extension for submitting
bioequivalence study data for ANDA
078320. On September 21, 2011, FDA
issued a letter to InvaGen
acknowledging InvaGen’s August 12,
2011, request for an extension. In a
letter to FDA dated September 6, 2012,
InvaGen requested an additional 6month extension to submit
bioequivalence study data; and in a
letter to FDA dated October 4, 2012,
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Federal Register / Vol. 85, No. 134 / Monday, July 13, 2020 / Notices
InvaGen requested that FDA consider
and grant InvaGen’s request for an
extension. On October 23, 2012, FDA
issued a letter to InvaGen granting
InvaGen an extension until March 2013
to submit bioequivalence study data.
InvaGen has not submitted the
bioequivalence study data.
The additional correspondence noted
above that was not identified in the
October 28, 2019, NOOH does not alter
the underlying basis of the October 28,
2019, NOOH. In the absence of
information showing bioequivalence
between the generic drug at issue and
the reference listed drug (RLD), there is
no basis for concluding that the
Agency’s finding of safety and efficacy
supporting approval of the RLD can be
used as a basis to support approval of
the generic drug. Section 505(e) of the
FD&C Act provides FDA the authority to
withdraw approval of an ANDA in these
circumstances.
In correspondence dated November 7,
2019, InvaGen requested withdrawal of
the approval of ANDA 078320 under
§ 314.150(d). Because this application
withdrawal is effectuated through the
NOOH process (see 84 FR 57736),
InvaGen’s request to withdraw approval
under § 314.150(d) is moot. In the
November 7, 2019, correspondence,
InvaGen also waived its opportunity for
a hearing under § 314.150(a).
FDA finds that InvaGen has
repeatedly failed to submit the required
data to support a finding of
bioequivalence for ANDA 078320. In
addition, under 21 CFR 314.200, FDA
finds that InvaGen has waived any
contentions concerning the legal status
of the drug product. Therefore, under
section 505(e) of the FD&C Act,
approval of ANDA 078320, and all
amendments and supplements thereto,
is withdrawn (see DATES). Introduction
or delivery for introduction of this drug
product into 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), 331(d))).
Dated: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
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[FR Doc. 2020–14981 Filed 7–10–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–E–4404]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; CARTIVA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for CARTIVA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
SUMMARY:
Anyone with knowledge that any
of the dates as published (in
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by September 11, 2020.
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
January 11, 2021. 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 September 11,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 11, 2020.
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.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
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41999
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–E–4404 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; CARTIVA.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
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Agencies
[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Pages 41998-41999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14981]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3708]
InvaGen Pharmaceuticals, Inc.; Withdrawal of Approval of an
Abbreviated New Drug Application for Trandolapril Tablets
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) is withdrawing approval of an
abbreviated new drug application (ANDA) for trandolapril tablets. The
basis for the withdrawal is that the holder of the ANDA has repeatedly
failed to submit the required data to support a finding of
bioequivalence for this ANDA. The holder of the ANDA has waived its
opportunity for a hearing.
DATES: Withdrawal of approval is applicable July 13, 2020.
FOR FURTHER INFORMATION CONTACT: Jennifer Forde, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-
348-3035.
SUPPLEMENTARY INFORMATION: FDA's Office of Generic Drugs (OGD) approved
ANDA 078320, held by InvaGen Pharmaceuticals, Inc. (InvaGen), for a
generic version of trandolapril tablets, 1 milligram (mg), 2 mg, and 4
mg, under the requirements of section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) and FDA's implementing
regulations. OGD approved ANDA 078320 on June 12, 2007. In a notice
published in the Federal Register of October 28, 2019 (84 FR 57736),
CDER notified InvaGen of CDER's proposal to issue an order, under
section 505(e) of the FD&C Act and Sec. 314.150 (21 CFR 314.150),
withdrawing approval of ANDA 078320 and all amendments and supplements
to it on the grounds that InvaGen has failed to submit the required
bioequivalence data necessary to demonstrate the bioequivalence of its
drug product. In its October 28, 2019, notice of opportunity for a
hearing (NOOH), CDER provided InvaGen with an opportunity to request a
hearing to show why approval of ANDA 078320 should not be withdrawn.
As noted in the October 28, 2019, NOOH, FDA issued a letter to
InvaGen on August 9, 2011, regarding ANDA 078320 because this drug
product application was supported by bioequivalence studies with the
bioanalytical analysis conducted by Cetero Research at the Houston, TX,
site between April 1, 2005, and June 15, 2010. As FDA noted in its
August 9, 2011, correspondence, inspection findings regarding Cetero
Research's bioequivalence studies raised significant concerns about the
validity of the reported results of the analytical studies conducted
between April 2005 and June 2010 in support of drug applications, and
as such, steps needed to be taken to demonstrate the bioequivalence of
InvaGen's drug product approved under ANDA 078320. FDA informed InvaGen
that ANDA 078320 needed to be supplemented by conducting new
bioequivalence studies or re-assaying the samples from the original
bioequivalence study. FDA recommended to InvaGen that the results of
the requested bioequivalence studies or re-assays be submitted to ANDA
078320 within 6 months of the date of the August 9, 2011, letter.
Although the October 28, 2019, NOOH states that FDA did not receive
a response from InvaGen to the August 9, 2011, letter from FDA, upon
further review, additional correspondence between InvaGen and FDA has
been identified. In a letter to FDA dated August 12, 2011, InvaGen
requested a 6-month extension for submitting bioequivalence study data
for ANDA 078320. On September 21, 2011, FDA issued a letter to InvaGen
acknowledging InvaGen's August 12, 2011, request for an extension. In a
letter to FDA dated September 6, 2012, InvaGen requested an additional
6-month extension to submit bioequivalence study data; and in a letter
to FDA dated October 4, 2012,
[[Page 41999]]
InvaGen requested that FDA consider and grant InvaGen's request for an
extension. On October 23, 2012, FDA issued a letter to InvaGen granting
InvaGen an extension until March 2013 to submit bioequivalence study
data. InvaGen has not submitted the bioequivalence study data.
The additional correspondence noted above that was not identified
in the October 28, 2019, NOOH does not alter the underlying basis of
the October 28, 2019, NOOH. In the absence of information showing
bioequivalence between the generic drug at issue and the reference
listed drug (RLD), there is no basis for concluding that the Agency's
finding of safety and efficacy supporting approval of the RLD can be
used as a basis to support approval of the generic drug. Section 505(e)
of the FD&C Act provides FDA the authority to withdraw approval of an
ANDA in these circumstances.
In correspondence dated November 7, 2019, InvaGen requested
withdrawal of the approval of ANDA 078320 under Sec. 314.150(d).
Because this application withdrawal is effectuated through the NOOH
process (see 84 FR 57736), InvaGen's request to withdraw approval under
Sec. 314.150(d) is moot. In the November 7, 2019, correspondence,
InvaGen also waived its opportunity for a hearing under Sec.
314.150(a).
FDA finds that InvaGen has repeatedly failed to submit the required
data to support a finding of bioequivalence for ANDA 078320. In
addition, under 21 CFR 314.200, FDA finds that InvaGen has waived any
contentions concerning the legal status of the drug product. Therefore,
under section 505(e) of the FD&C Act, approval of ANDA 078320, and all
amendments and supplements thereto, is withdrawn (see DATES).
Introduction or delivery for introduction of this drug product into
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), 331(d))).
Dated: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14981 Filed 7-10-20; 8:45 am]
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