Sanofi-Aventis, U.S., LLC, et al.; Withdrawal of Approval of 20 New Drug Applications, 53068-53069 [2018-22805]
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53068
Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Notices
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
amozie on DSK3GDR082PROD with NOTICES1
A regulatory review period consists of
two periods of time: a testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
and runs until the approval phase
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
product. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(for example, half the testing phase must
be subtracted as well as any time that
may have occurred before the patent
was issued), FDA’s determination of the
length of a regulatory review period for
a human biological product will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human biologic product IMFINZI
(durvalumab). IMFINZI is indicated for
the treatment of patients with locally
advanced or metastatic urothelial
carcinoma who have disease
progression during or following
platinum-containing chemotherapy or
who have disease progression within 12
months of neoadjuvant or adjuvant
treatment with platinum-containing
chemotherapy. This indication is
approved under accelerated approval
based on tumor response rate and
duration of response. Continued
approval for this indication may be
contingent upon verification and
description of clinical benefit in
confirmatory trials. Subsequent to this
approval, the USPTO received a patent
term restoration application for IMFINZI
(U.S. Patent Nos. 8,779,108 and
9,493,565) from MedImmune Limited,
and the USPTO requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated, January 9, 2018, FDA
advised the USPTO that this human
biological product had undergone a
regulatory review period and that the
approval of IMFINZI 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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18:10 Oct 18, 2018
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II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
IMFINZI is 1,755 days. Of this time,
1,554 days occurred during the testing
phase of the regulatory review period,
while 201 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 (21 U.S.C. 355(i))
became effective: July 13, 2012. FDA has
verified the applicant’s claim that the
date the initial investigational new drug
application became effective was on
July 13, 2012.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): October 13, 2016. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
IMFINZI (BLA 761069) was initially
submitted on October 13, 2016.
3. The date the application was
approved: May 1, 2017. FDA has
verified the applicant’s claim that BLA
761069 was approved on May 1, 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 159 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
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.
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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: October 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22806 Filed 10–18–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3761]
Sanofi-Aventis, U.S., LLC, et al.;
Withdrawal of Approval of 20 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 20 new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
SUMMARY:
Approval is withdrawn as of
November 19, 2018.
DATES:
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Notices
Application No.
Drug
NDA 006002 ......
Aralen Hydrochloride (chloroquine hydrochloride
(HCl)) Injection, Equivalent to (EQ) 40 milligram (mg) base/milliliter (mL); Aralen
(chloroquine phosphate) Tablets, EQ 300 mg
base.
Leucovorin calcium for Injection USP, EQ 60 mg
base/vial for solution, oral; EQ 3 mg base/mL
injection; EQ 50 mg base/vial injection; EQ
100 mg base/vial injection; EQ 350 mg base/
vial injection.
Cholografin Meglumine (iodipamide meglumine)
Injection, 10.3% and 52% (cholografin sodium,
20%).
Brevicon (ethinyl estradiol; norethindrone) Tablets, 0.035 mg/0.5 mg (21-Day Regimen).
Mycelex (clotrimazole) Topical Solution, 1% .......
NDA 008107 ......
NDA 009321 ......
NDA 017566 ......
NDA 018181 ......
NDA 018182 ......
NDA 018183 ......
NDA 018230 ......
NDA 018856 ......
NDA 018874 ......
NDA 020214 ......
NDA 020389 ......
NDA 020528 ......
NDA 020738 ......
NDA 020863 ......
NDA 021268 ......
NDA 021410 ......
NDA 021511 ......
NDA 021700 ......
amozie on DSK3GDR082PROD with NOTICES1
NDA 205123 ......
VerDate Sep<11>2014
Applicant
Mycelex-7 (clotrimazole) Tablets, 100 mg ...........
Mycelex (clotrimazole) Topical Cream, 1% ..........
Mycelex-7 (clotrimazole) Topical Vaginal Cream,
1%.
D-Xylose (xylose) Powder, 25 grams (g)/bottle ...
Calcijex (calcitriol) Injection, 0.001 mg/mL and
0.002 mg/mL.
Zemuron (rocronium bromide) Injection, 50 mg/5
mL (10 mg/mL); 10 mg/mL (10 mg/mL); 100
mg/10 mL (10 mg/mL).
Mycelex-7 Combination Pack (clotrimazole) Topical Vaginal Cream and Tablets, 1%, 100 mg.
Mavik (trandolapril) Tablets, 1 mg, 2 mg, and 4
mg.
Teveten (eprosartan mesylate) Tablets, 300 mg,
400 mg, and 600 mg.
Pletal (cilostazol) Tablets, 50 mg and 100 mg ....
Teveten HCT (eprosartan mesylate and
hydrochlorothiazide) Tablets, 600/12.5 mg and
600/25 mg.
Avandamet (rosiglitazone maleate and metformin
hydrochloride (HCl)) Tablets, 500 mg EQ 1 mg
base; 500 mg EQ 2 mg base; 500 mg EQ 4
mg base; 1 g EQ 2 mg base; 1 g EQ 4 mg
base.
Copegus (ribavirin) Tablets, 200 mg and 400 mg
Avandaryl (glimepiride and rosiglitazone maleate) Tablets, 1 mg/4 mg; 2 mg/4 mg; 2 mg/8
mg; 4 mg/4 mg; 4 mg/8 mg.
Olysio (simeprevir sodium) Capsules, EQ 150
mg base.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of November 19,
2018. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on November 19,
2018 may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
17:25 Oct 18, 2018
Jkt 247001
53069
Sanofi-Aventis, U.S., LLC, 55 Corporate Dr., Bridgewater, NJ 08807.
Hospira Inc., Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY
10017.
Bracco Diagnostics, Inc., 259 Prospect Plains Rd., Monroe Township, NJ
08831.
Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC,
2525 Dupont Dr., Irvine, CA 92612.
Bayer HealthCare LLC, 100 Bayer Blvd., 100 Bayer Rd., Pittsburgh, PA
15205.
Do.
Do.
Do.
Lyne Laboratories, 10 Burke Dr., Brockton, MA 02301.
AbbVie, Inc., 1 North Waukegan Rd., North Chicago, IL 60064.
Organon USA Inc., Subsidiary of Merck & Co., Inc., 2000 Galloping Hill
Rd., Kenilworth, NJ 07033.
Bayer HealthCare LLC.
AbbVie, Inc.
Do.
Otsuka Pharmaceutical Development and Commercialization, Subsidiary
of Otsuka Pharmaceutical Company, Ltd., 2440 Research Blvd., Rockville, MD 20850.
AbbVie, Inc.
GlaxoSmithKline, 1250 South Collegeville Rd., Collegeville, PA 19426.
Hoffmann La-Roche, Inc., Subsidiary of Genentech, Inc., 1 DNA Way,
South San Francisco, CA 94080.
SB Pharmco Puerto Rico Inc., Subsidiary of GlaxoSmithKline, 1250
South Collegeville Rd., Collegeville, PA 19426.
Janssen Pharmaceuticals, Inc., 1000 U.S. Rte. 202 South, Raritan, NJ
08869.
Dated: October 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22805 Filed 10–18–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
PO 00000
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amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
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]]>Agencies
[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Notices]
[Pages 53068-53069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22805]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3761]
Sanofi-Aventis, U.S., LLC, et al.; Withdrawal of Approval of 20
New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 20 new drug applications (NDAs) from multiple
applicants. The applicants notified the Agency in writing that the drug
products were no longer marketed and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of November 19, 2018.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec. 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
[[Page 53069]]
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Application No. Drug Applicant
----------------------------------------------------------------------------------------------------------------
NDA 006002....................... Aralen Hydrochloride (chloroquine Sanofi-Aventis, U.S., LLC, 55 Corporate
hydrochloride (HCl)) Injection, Dr., Bridgewater, NJ 08807.
Equivalent to (EQ) 40 milligram
(mg) base/milliliter (mL);
Aralen (chloroquine phosphate)
Tablets, EQ 300 mg base.
NDA 008107....................... Leucovorin calcium for Injection Hospira Inc., Subsidiary of Pfizer Inc.,
USP, EQ 60 mg base/vial for 235 East 42nd St., New York, NY 10017.
solution, oral; EQ 3 mg base/mL
injection; EQ 50 mg base/vial
injection; EQ 100 mg base/vial
injection; EQ 350 mg base/vial
injection.
NDA 009321....................... Cholografin Meglumine (iodipamide Bracco Diagnostics, Inc., 259 Prospect
meglumine) Injection, 10.3% and Plains Rd., Monroe Township, NJ 08831.
52% (cholografin sodium, 20%).
NDA 017566....................... Brevicon (ethinyl estradiol; Allergan Pharmaceuticals International,
norethindrone) Tablets, 0.035 mg/ Ltd., c/o Allergan Sales, LLC, 2525
0.5 mg (21-Day Regimen). Dupont Dr., Irvine, CA 92612.
NDA 018181....................... Mycelex (clotrimazole) Topical Bayer HealthCare LLC, 100 Bayer Blvd., 100
Solution, 1%. Bayer Rd., Pittsburgh, PA 15205.
NDA 018182....................... Mycelex-7 (clotrimazole) Tablets, Do.
100 mg.
NDA 018183....................... Mycelex (clotrimazole) Topical Do.
Cream, 1%.
NDA 018230....................... Mycelex-7 (clotrimazole) Topical Do.
Vaginal Cream, 1%.
NDA 018856....................... D-Xylose (xylose) Powder, 25 Lyne Laboratories, 10 Burke Dr., Brockton,
grams (g)/bottle. MA 02301.
NDA 018874....................... Calcijex (calcitriol) Injection, AbbVie, Inc., 1 North Waukegan Rd., North
0.001 mg/mL and 0.002 mg/mL. Chicago, IL 60064.
NDA 020214....................... Zemuron (rocronium bromide) Organon USA Inc., Subsidiary of Merck &
Injection, 50 mg/5 mL (10 mg/ Co., Inc., 2000 Galloping Hill Rd.,
mL); 10 mg/mL (10 mg/mL); 100 mg/ Kenilworth, NJ 07033.
10 mL (10 mg/mL).
NDA 020389....................... Mycelex-7 Combination Pack Bayer HealthCare LLC.
(clotrimazole) Topical Vaginal
Cream and Tablets, 1%, 100 mg.
NDA 020528....................... Mavik (trandolapril) Tablets, 1 AbbVie, Inc.
mg, 2 mg, and 4 mg.
NDA 020738....................... Teveten (eprosartan mesylate) Do.
Tablets, 300 mg, 400 mg, and 600
mg.
NDA 020863....................... Pletal (cilostazol) Tablets, 50 Otsuka Pharmaceutical Development and
mg and 100 mg. Commercialization, Subsidiary of Otsuka
Pharmaceutical Company, Ltd., 2440
Research Blvd., Rockville, MD 20850.
NDA 021268....................... Teveten HCT (eprosartan mesylate AbbVie, Inc.
and hydrochlorothiazide)
Tablets, 600/12.5 mg and 600/25
mg.
NDA 021410....................... Avandamet (rosiglitazone maleate GlaxoSmithKline, 1250 South Collegeville
and metformin hydrochloride Rd., Collegeville, PA 19426.
(HCl)) Tablets, 500 mg EQ 1 mg
base; 500 mg EQ 2 mg base; 500
mg EQ 4 mg base; 1 g EQ 2 mg
base; 1 g EQ 4 mg base.
NDA 021511....................... Copegus (ribavirin) Tablets, 200 Hoffmann La-Roche, Inc., Subsidiary of
mg and 400 mg. Genentech, Inc., 1 DNA Way, South San
Francisco, CA 94080.
NDA 021700....................... Avandaryl (glimepiride and SB Pharmco Puerto Rico Inc., Subsidiary of
rosiglitazone maleate) Tablets, GlaxoSmithKline, 1250 South Collegeville
1 mg/4 mg; 2 mg/4 mg; 2 mg/8 mg; Rd., Collegeville, PA 19426.
4 mg/4 mg; 4 mg/8 mg.
NDA 205123....................... Olysio (simeprevir sodium) Janssen Pharmaceuticals, Inc., 1000 U.S.
Capsules, EQ 150 mg base. Rte. 202 South, Raritan, NJ 08869.
----------------------------------------------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
November 19, 2018. Introduction or delivery for introduction into
interstate commerce of products without approved new drug applications
violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the
table that are in inventory on November 19, 2018 may continue to be
dispensed until the inventories have been depleted or the drug products
have reached their expiration dates or otherwise become violative,
whichever occurs first.
Dated: October 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22805 Filed 10-18-18; 8:45 am]
BILLING CODE 4164-01-P
