Delcor Asset Corp. et al.; Withdrawal of Approval of 22 Abbreviated New Drug Applications, 2455-2456 [2018-00695]
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Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices
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 DAKLINZA
(daclatasvir dihydrochloride).
DAKLINZA is indicated for use with
sofosbuvir for the treatment of chronic
HCV genotype 3 infection. Subsequent
to this approval, the USPTO received a
patent term restoration application for
DAKLINZA (U.S. Patent No. 8,329,159)
from Bristol-Myers Squibb Company,
and the USPTO requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated July 12, 2016, FDA
advised the USPTO that this human
drug product had undergone a
regulatory review period and that the
approval of DAKLINZA 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
DAKLINZA is 2,808 days. Of this time,
2,327 days occurred during the testing
phase of the regulatory review period,
while 481 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: November 17, 2007.
The applicant claims November 16, 2007, as
the date the investigational new drug
application (IND) became effective. However,
FDA records indicate that the IND effective
date was November 17, 2007, which was 30
days after FDA receipt of the IND.
2. The date the application was initially
submitted with respect to the human drug
product under section 505(b) of the FD&C
Act: March 31, 2014. FDA has verified the
applicant’s claim that the new drug
application (NDA) for DAKLINZA (NDA
206843) was initially submitted on March 31,
2014.
3. The date the application was approved:
July 24, 2015. FDA has verified the
applicant’s claim that NDA 206843 was
approved on July 24, 2015.
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 467 days of patent
term extension.
2455
Dated: January 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00675 Filed 1–16–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0002]
Delcor Asset Corp. et al.; Withdrawal
of Approval of 22 Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Notice.
III. Petitions
ACTION:
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.
SUMMARY:
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 22 abbreviated
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
February 16, 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,
Trang.Tran@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
holders of the applications listed in
table 1 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.
DATES:
TABLE 1—ANDAS FOR WHICH FDA IS WITHDRAWING APPROVAL
Drug
Applicant
ANDA 060577 ..........
ethrower on DSK3G9T082PROD with NOTICES
Application No.
Mycostatin (nystatin) Vaginal Tablets, 100,000 units ...........
ANDA 063302 ..........
Cefamandole Nafate for Injection .........................................
ANDA 070462 ..........
Diazepam Tablets USP, 2 milligrams (mg) ..........................
ANDA 070463 ..........
ANDA 070998 ..........
Diazepam Tablets USP, 5 mg ..............................................
Potassium Chloride Extended-Release Tablets, 8 milliequivalents (mEq).
Potassium Chloride Extended-Release Tablets, 10 mEq ....
Delcor Asset Corp., 411 South State St., Suite E–100,
Newtown, PA 18940.
ACS Dobfar SpA, c/o Interchem Corp., 120 Route 17
North, Paramus, NJ 07653.
Virtus Pharmaceuticals, 12 Penns Trail, Newtown, PA
18940.
Do.
Future Pak, Ltd., 28115 Lakeview Dr., Wixom, MI 48393.
ANDA 070999 ..........
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Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices
TABLE 1—ANDAS FOR WHICH FDA IS WITHDRAWING APPROVAL—Continued
Application No.
Drug
Applicant
ANDA 075375 ..........
Diltiazem Hydrochloride (HCl) Injection, 5 mg/milliliter (mL)
ANDA 076911 ..........
Clorazepate Dipotassium Tablets USP, 3.75 mg, 7.5 mg,
and 15 mg.
ANDA 077102 ..........
Calcitriol Injection, 0.001 mg/mL ...........................................
ANDA 084656 ..........
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/30 mg.
Diphenhydramine HCl Capsules, 25 mg ..............................
Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc.,
781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown,
WV 26504.
Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton,
NJ 08540.
Sagent Pharmaceuticals, Inc., 1901 N. Roselle Rd., Suite
450, Schaumburg, IL 60195.
Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus,
OH 43228.
LNK International, Inc., 145 Ricefield Ln., Hauppauge, NY
11788.
LyphoMed, Division of Fujisawa USA, Inc., 2045 North
Cornell Ave., Melrose Park, IL 60160.
Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth,
NJ 07207.
Superpharm Corp., 1769 Fifth Ave., Bayshore, NY 11706.
ANDA 087977 ..........
ANDA 088676 ..........
ANDA 089080 ..........
ANDA 089183 ..........
ANDA 089253 ..........
ANDA 089219 ..........
ANDA 089254 ..........
ANDA 089369 ..........
ANDA 089481 ..........
ANDA 089482 ..........
ANDA 089483 ..........
ANDA 206711 ..........
Methylprednisolone Sodium Succinate for Injection USP,
Equivalent to 40 mg base/vial.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/30 mg.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/15 mg.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/30 mg.
Procainamide HCl Capsules USP, 250 mg, 375 mg, and
500 mg.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/60 mg.
Procainamide HCl Extended-Release Tablets USP, 250
mg, 500 mg, and 750 mg.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/15 mg.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/30 mg.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/60 mg.
Olanzapine Tablets USP, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15
mg, and 20 mg.
ethrower on DSK3G9T082PROD with NOTICES
Therefore, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn as of February 16,
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 table 1
that are in inventory on the date that
this notice becomes effective (see the
DATES section) 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: January 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00695 Filed 1–16–18; 8:45 am]
BILLING CODE 4164–01–P
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IDT Australia, Ltd., c/o Facet Life Sciences, Inc., 6122
Stone Wolfe Dr., Glen Carbon, IL 62034.
Do.
Do.
American Therapeutics, Inc., 75 Carlough Rd., Bohemia,
NY 11716.
Do.
Do.
Ajanta Pharma, Ltd., c/o Ajanta Pharma USA, Inc., One
Grande Commons, 440 U.S. Highway 22 East, Suite
150, Bridgewater, NJ 08807.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0155]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Veterinary Feed
Directive
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
SUMMARY:
PO 00000
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collection provisions of our veterinary
feed directive (VFD) regulation.
DATES: Submit either electronic or
written comments on the collection of
information by March 19, 2018.
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 March 19,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of March 19, 2018. 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.
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
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[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Notices]
[Pages 2455-2456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00695]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0002]
Delcor Asset Corp. et al.; Withdrawal of Approval of 22
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 22 abbreviated 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 February 16, 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
table 1 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.
Table 1--ANDAs for Which FDA Is Withdrawing Approval
----------------------------------------------------------------------------------------------------------------
Application No. Drug Applicant
----------------------------------------------------------------------------------------------------------------
ANDA 060577........................ Mycostatin (nystatin) Vaginal Delcor Asset Corp., 411 South State
Tablets, 100,000 units. St., Suite E-100, Newtown, PA
18940.
ANDA 063302........................ Cefamandole Nafate for Injection..... ACS Dobfar SpA, c/o Interchem Corp.,
120 Route 17 North, Paramus, NJ
07653.
ANDA 070462........................ Diazepam Tablets USP, 2 milligrams Virtus Pharmaceuticals, 12 Penns
(mg). Trail, Newtown, PA 18940.
ANDA 070463........................ Diazepam Tablets USP, 5 mg........... Do.
ANDA 070998........................ Potassium Chloride Extended-Release Future Pak, Ltd., 28115 Lakeview
Tablets, 8 milliequivalents (mEq). Dr., Wixom, MI 48393.
ANDA 070999........................ Potassium Chloride Extended-Release Do.
Tablets, 10 mEq.
[[Page 2456]]
ANDA 075375........................ Diltiazem Hydrochloride (HCl) Mylan Laboratories, Ltd., c/o Mylan
Injection, 5 mg/milliliter (mL). Pharmaceuticals, Inc., 781 Chestnut
Ridge Rd., P.O. Box 4310,
Morgantown, WV 26504.
ANDA 076911........................ Clorazepate Dipotassium Tablets USP, Sun Pharmaceutical Industries, Ltd.,
3.75 mg, 7.5 mg, and 15 mg. c/o Sun Pharmaceutical Industries,
Inc., 2 Independence Way,
Princeton, NJ 08540.
ANDA 077102........................ Calcitriol Injection, 0.001 mg/mL.... Sagent Pharmaceuticals, Inc., 1901
N. Roselle Rd., Suite 450,
Schaumburg, IL 60195.
ANDA 084656........................ Acetaminophen and Codeine Phosphate Roxane Laboratories, Inc., 1809
Tablets USP, 300 mg/30 mg. Wilson Rd., Columbus, OH 43228.
ANDA 087977........................ Diphenhydramine HCl Capsules, 25 mg.. LNK International, Inc., 145
Ricefield Ln., Hauppauge, NY 11788.
ANDA 088676........................ Methylprednisolone Sodium Succinate LyphoMed, Division of Fujisawa USA,
for Injection USP, Equivalent to 40 Inc., 2045 North Cornell Ave.,
mg base/vial. Melrose Park, IL 60160.
ANDA 089080........................ Acetaminophen and Codeine Phosphate Purepac Pharmaceutical Co., 200
Tablets USP, 300 mg/30 mg. Elmora Ave., Elizabeth, NJ 07207.
ANDA 089183........................ Acetaminophen and Codeine Phosphate Superpharm Corp., 1769 Fifth Ave.,
Tablets USP, 300 mg/15 mg. Bayshore, NY 11706.
ANDA 089253........................ Acetaminophen and Codeine Phosphate Do.
Tablets USP, 300 mg/30 mg.
ANDA 089219........................ Procainamide HCl Capsules USP, 250 IDT Australia, Ltd., c/o Facet Life
mg, 375 mg, and 500 mg. Sciences, Inc., 6122 Stone Wolfe
Dr., Glen Carbon, IL 62034.
ANDA 089254........................ Acetaminophen and Codeine Phosphate Do.
Tablets USP, 300 mg/60 mg.
ANDA 089369........................ Procainamide HCl Extended-Release Do.
Tablets USP, 250 mg, 500 mg, and 750
mg.
ANDA 089481........................ Acetaminophen and Codeine Phosphate American Therapeutics, Inc., 75
Tablets USP, 300 mg/15 mg. Carlough Rd., Bohemia, NY 11716.
ANDA 089482........................ Acetaminophen and Codeine Phosphate Do.
Tablets USP, 300 mg/30 mg.
ANDA 089483........................ Acetaminophen and Codeine Phosphate Do.
Tablets USP, 300 mg/60 mg.
ANDA 206711........................ Olanzapine Tablets USP, 2.5 mg, 5 mg, Ajanta Pharma, Ltd., c/o Ajanta
7.5 mg, 10 mg, 15 mg, and 20 mg. Pharma USA, Inc., One Grande
Commons, 440 U.S. Highway 22 East,
Suite 150, Bridgewater, NJ 08807.
----------------------------------------------------------------------------------------------------------------
Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of February
16, 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 table 1 that
are in inventory on the date that this notice becomes effective (see
the DATES section) 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: January 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00695 Filed 1-16-18; 8:45 am]
BILLING CODE 4164-01-P
