Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications, 8089-8090 [2018-03700]
Download as PDF
<![CDATA[
Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
daltland on DSKBBV9HB2PROD with NOTICES
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
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.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug 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 drug 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 drug product ZYDELIG
(idelalisib). As approved in both NDA
206545 and NDA 205858, ZYDELIG is
indicated for treatment of patients with:
• Relapsed chronic lymphocytic
leukemia in combination with
rituximab, in patients for whom
rituximab alone would be considered
appropriate therapy due to other comorbidities.
• Relapsed follicular B-cell nonHodgkin lymphoma (FL) in patients
VerDate Sep<11>2014
18:52 Feb 22, 2018
Jkt 244001
who have received at least two prior
systemic therapies.
• Relapsed small lymphocytic
lymphoma (SLL) in patients who have
received at least two prior systemic
therapies.
Accelerated approval was granted for
FL and SLL based on overall response
rate. Improvement in patient survival or
disease related symptoms has not been
established. Continued approval for
these indications may be contingent
upon verification of clinical benefit in
confirmatory trials.
Subsequent to the approvals, the
USPTO received patent term restoration
applications for ZYDELIG (U.S. Patent
Nos. RE44599 and RE44638) from ICOS
Corporation, and the USPTO requested
FDA’s assistance in determining the
patents’ eligibility for patent term
restoration. In a letter dated November
4, 2015, FDA advised the USPTO that
this human drug product had undergone
a regulatory review period and that the
approvals of ZYDELIG under NDA
206545 and NDA 205858 represented
the first permitted commercial
marketing or use of the product.
Thereafter, the USPTO requested that
FDA determine the product’s regulatory
review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
ZYDELIG is 2,247 days. Of this time,
2,017 days occurred during the testing
phase of the regulatory review period,
while 230 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 (the FD&C Act) (21
U.S.C. 355(i)) became effective: May 30,
2008. FDA has verified the applicant’s
claim that the date the investigational
new drug application (IND) became
effective was on May 30, 2008. This is
the same IND and the same date FDA
determined as the beginning of the
regulatory review period for ZYDELIG
approved under NDA 205858. The
regulatory review period for ZYDELIG
approved under NDA 205858 is
publishing in this issue of the Federal
Register.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: December 6,
2013. FDA has verified the applicant’s
claims that the NDA for ZYDELIG (NDA
206545) was initially submitted on
December 6, 2013.
3. The date the application was
approved: July 23, 2014. FDA has
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
8089
verified the applicant’s claims that NDA
206545 was approved on July 23, 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 applications for patent extension,
this applicant seeks 494 days or 708
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.
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: February 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03701 Filed 2–22–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0478]
Sebela Ireland, Ltd. et al.; Withdrawal
of Approval of 24 Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 24 abbreviated
SUMMARY:
E:\FR\FM\23FEN1.SGM
23FEN1
8090
Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices
new drug applications (ANDAs) from
multiple applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
Approval is withdrawn as of
March 26, 2018.
DATES:
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1671, Silver Spring,
MD 20993–0002, 240–402–7945,
Trang.Tran@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
holders of the applications 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 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.
Application No.
Drug
Applicant
ANDA 040398 ....
MiCort-HC (hydrocortisone acetate) Cream USP, 2% ............
ANDA 071893 ....
Acetohexamide Tablets, 250 milligrams (mg) .........................
ANDA
ANDA
ANDA
ANDA
....
....
....
....
Acetohexamide Tablets, 500 mg .............................................
Cyclobenzaprine Hydrochloride (HCl) Tablets USP, 10 mg ....
Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mg
Quinapril Tablets USP, Equivalent to (EQ) 5 mg base, EQ 10
mg base, EQ 20 mg base, and EQ 40 mg base.
ANDA 076786 ....
ANDA 077483 ....
ANDA 078502 ....
Donepezil HCl Tablets USP, 5 mg and 10 mg ........................
Benazepril HCl and Hydrochlorothiazide Tablets, 5 mg/6.25
mg, 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg.
Eliphos (calcium acetate) Tablets USP, 667 mg .....................
Sebela Ireland, Ltd., c/o Sebela Pharmaceuticals, Inc., 645
Hembree Parkway, Suite 1, Roswell, GA 30076.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Do.
Do.
Do.
Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical
Industries, Inc., 2 Independence Way, Princeton, NJ
08540.
Do.
Do.
ANDA 081019 ....
Chlorzoxazone Tablets USP, 500 mg .....................................
ANDA
ANDA
ANDA
ANDA
....
....
....
....
Brompheniramine Maleate Injection, 10 mg/milliliter (mL) ......
Bethanechol Chloride Tablets USP, 10 mg .............................
Bethanechol Chloride Tablets USP, 25 mg .............................
Theolair (theophylline) Tablets, 125 mg and 250 mg ..............
ANDA 085738 ....
ANDA 087444 ....
Betamethasone Sodium Phosphate Injection, EQ 3 mg base/
mL.
Bethanechol Chloride Tablets USP, 50 mg .............................
ANDA 087792 ....
Fluorouracil Injection USP, 50 mg/mL .....................................
ANDA 087978 ....
Diphenhydramine HCl Capsules, 50 mg .................................
ANDA 090417 ....
ANDA 090418 ....
ANDA 090468 ....
Carbinoxamine Maleate Tablets USP, 4 mg ...........................
Carbinoxamine Maleate Oral Solution, 4 mg/5 mL .................
Zyfrel (acetaminophen and hydrocodone bitartrate) Oral Solution, 325 mg/7.5 mg per 15 mL.
Dorzolamide HCl Ophthalmic Solution USP, EQ 2% base .....
071894
073143
074576
076607
083821
084408
084441
085283
ANDA 091034 ....
ANDA 200794 ....
daltland on DSKBBV9HB2PROD with NOTICES
ANDA 206438 ....
Pantoprazole Sodium Delayed-Release Tablets USP, EQ 20
mg base and EQ 40 mg base.
Hydrocodone Bitartrate and Chlorpheniramine Maleate Oral
Solution, 5 mg/4 mg per 5 mL.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of March 26,
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 March 26, 2018
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
VerDate Sep<11>2014
18:52 Feb 22, 2018
Jkt 244001
Cypress Pharmaceutical, Inc., 10 North Park Pl., Suite 201,
Morristown, NJ 07960.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Do.
Do.
Do.
3M Drug Delivery Systems, 3M Center, Bldg. 275–3E–02,
2510 Conway Ave., St. Paul, MN 55144.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Spectrum Pharmaceuticals, Inc., 157 Technology Dr., Irvine,
CA 92618.
LNK International, Inc., 145 Ricefield Ln., Hauppauge, NY
11788.
Cypress Pharmaceutical, Inc.
Do.
Do.
Zambon S.p.A., c/o Camargo Pharmaceutical Services, LLC,
9825 Kenwood Rd., Suite 203, Cincinnati, OH 45242.
Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical
Industries, Inc.
Tris Pharma, Inc., 2033 Route 130, Suite D, Monmouth
Junction, NJ 08852.
expiration dates or otherwise become
violative, whichever occurs first.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: February 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
[FR Doc. 2018–03700 Filed 2–22–18; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
notice is hereby given that the
Secretary’s Advisory Committee on
SUMMARY:
Frm 00046
Fmt 4703
Sfmt 4703
E:\FR\FM\23FEN1.SGM
23FEN1
]]>Agencies
[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Notices]
[Pages 8089-8090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03700]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0478]
Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 24 abbreviated
[[Page 8090]]
new drug applications (ANDAs) from multiple applicants. The holders of
the applications 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 March 26, 2018.
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945,
[email protected].
SUPPLEMENTARY INFORMATION: The holders of the applications 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 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.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 040398............ MiCort-HC Sebela Ireland, Ltd.,
(hydrocortisone c/o Sebela
acetate) Cream USP, 2%. Pharmaceuticals,
Inc., 645 Hembree
Parkway, Suite 1,
Roswell, GA 30076.
ANDA 071893............ Acetohexamide Tablets, Watson Laboratories,
250 milligrams (mg). Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 071894............ Acetohexamide Tablets, Do.
500 mg.
ANDA 073143............ Cyclobenzaprine Do.
Hydrochloride (HCl)
Tablets USP, 10 mg.
ANDA 074576............ Captopril Tablets USP, Do.
12.5 mg, 25 mg, 50 mg,
and 100 mg.
ANDA 076607............ Quinapril Tablets USP, Sun Pharmaceutical
Equivalent to (EQ) 5 Industries, Ltd., c/o
mg base, EQ 10 mg Sun Pharmaceutical
base, EQ 20 mg base, Industries, Inc., 2
and EQ 40 mg base. Independence Way,
Princeton, NJ 08540.
ANDA 076786............ Donepezil HCl Tablets Do.
USP, 5 mg and 10 mg.
ANDA 077483............ Benazepril HCl and Do.
Hydrochlorothiazide
Tablets, 5 mg/6.25 mg,
10 mg/12.5 mg, 20 mg/
12.5 mg, and 20 mg/25
mg.
ANDA 078502............ Eliphos (calcium Cypress
acetate) Tablets USP, Pharmaceutical, Inc.,
667 mg. 10 North Park Pl.,
Suite 201,
Morristown, NJ 07960.
ANDA 081019............ Chlorzoxazone Tablets Watson Laboratories,
USP, 500 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 083821............ Brompheniramine Maleate Do.
Injection, 10 mg/
milliliter (mL).
ANDA 084408............ Bethanechol Chloride Do.
Tablets USP, 10 mg.
ANDA 084441............ Bethanechol Chloride Do.
Tablets USP, 25 mg.
ANDA 085283............ Theolair (theophylline) 3M Drug Delivery
Tablets, 125 mg and Systems, 3M Center,
250 mg. Bldg. 275-3E-02, 2510
Conway Ave., St.
Paul, MN 55144.
ANDA 085738............ Betamethasone Sodium Watson Laboratories,
Phosphate Injection, Inc., Subsidiary of
EQ 3 mg base/mL. Teva Pharmaceuticals
USA, Inc.
ANDA 087444............ Bethanechol Chloride Watson Laboratories,
Tablets USP, 50 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 087792............ Fluorouracil Injection Spectrum
USP, 50 mg/mL. Pharmaceuticals,
Inc., 157 Technology
Dr., Irvine, CA
92618.
ANDA 087978............ Diphenhydramine HCl LNK International,
Capsules, 50 mg. Inc., 145 Ricefield
Ln., Hauppauge, NY
11788.
ANDA 090417............ Carbinoxamine Maleate Cypress
Tablets USP, 4 mg. Pharmaceutical, Inc.
ANDA 090418............ Carbinoxamine Maleate Do.
Oral Solution, 4 mg/5
mL.
ANDA 090468............ Zyfrel (acetaminophen Do.
and hydrocodone
bitartrate) Oral
Solution, 325 mg/7.5
mg per 15 mL.
ANDA 091034............ Dorzolamide HCl Zambon S.p.A., c/o
Ophthalmic Solution Camargo
USP, EQ 2% base. Pharmaceutical
Services, LLC, 9825
Kenwood Rd., Suite
203, Cincinnati, OH
45242.
ANDA 200794............ Pantoprazole Sodium Sun Pharmaceutical
Delayed-Release Industries, Ltd., c/o
Tablets USP, EQ 20 mg Sun Pharmaceutical
base and EQ 40 mg base. Industries, Inc.
ANDA 206438............ Hydrocodone Bitartrate Tris Pharma, Inc.,
and Chlorpheniramine 2033 Route 130, Suite
Maleate Oral Solution, D, Monmouth Junction,
5 mg/4 mg per 5 mL. NJ 08852.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of March
26, 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 March 26, 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: February 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03700 Filed 2-22-18; 8:45 am]
BILLING CODE 4164-01-P
