83 FR 11208 - Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; Withdrawal of Approval of Four Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 50 (March 14, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 50 (March 14, 2018)
| Page Range | 11208-11208 | |
| FR Document | 2018-05120 |
[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)] [Notices] [Page 11208] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-05120] [[Page 11208]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0793] Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; Withdrawal of Approval of Four Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of four abbreviated new drug applications (ANDAs) from two 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of April 13, 2018.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 075556.................. Enalapril Maleate Sun Pharmaceutical Tablets USP, 2.5 Industries, Ltd., milligrams (mg), 5 c/o Sun mg, 10 mg, and 20 Pharmaceutical mg. Industries, Inc., 2 Independence Way, Princeton, NJ 08540. ANDA 076045.................. Lorazepam Tablets Do. USP, 0.5 mg, 1 mg, and 2 mg. ANDA 078055.................. Zolpidem Tartrate Do. Tablets USP, 5 mg and 10 mg. ANDA 090018.................. Zoledronic Acid for Sun Pharma Global Injection, FZE, c/o Sun Equivalent to 4 mg Pharmaceutical base/vial. Industries, Inc., 2 Independence Way, Princeton, NJ 08540. ------------------------------------------------------------------------ Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of April 13, 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 April 13, 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: March 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-05120 Filed 3-13-18; 8:45 am] BILLING CODE 4164-01-P
![11208 Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices
DEPARTMENT OF HEALTH AND approval of four abbreviated new drug MD 20993–0002, 240–402–7945,
HUMAN SERVICES applications (ANDAs) from two Trang.Tran@fda.hhs.gov.
applicants. The holders of the SUPPLEMENTARY INFORMATION: The
Food and Drug Administration applications notified the Agency in holders of the applications listed in the
[Docket No. FDA–2018–N–0793] writing that the drug products were no table have informed FDA that these drug
longer marketed and requested that the products are no longer marketed and
Sun Pharmaceutical Industries, Ltd., approval of the applications be have requested that FDA withdraw
and Sun Pharma Global FZE; withdrawn. approval of the applications under the
Withdrawal of Approval of Four process in § 314.150(c) (21 CFR
Abbreviated New Drug Applications DATES: Approval is withdrawn as of
April 13, 2018. 314.150(c)). The applicants have also,
AGENCY: Food and Drug Administration, by their requests, waived their
HHS. FOR FURTHER INFORMATION CONTACT: opportunity for a hearing. Withdrawal
ACTION: Notice. Trang Tran, Center for Drug Evaluation of approval of an application or
and Research, Food and Drug abbreviated application under
SUMMARY: The Food and Drug Administration, 10903 New Hampshire § 314.150(c) is without prejudice to
Administration (FDA) is withdrawing Ave., Bldg. 75, Rm. 1671, Silver Spring, refiling.
Application No. Drug Applicant
ANDA 075556 ........ Enalapril Maleate Tablets USP, 2.5 milligrams (mg), 5 mg, Sun Pharmaceutical Industries, Ltd., c/o Sun Pharma-
10 mg, and 20 mg. ceutical Industries, Inc., 2 Independence Way, Princeton,
NJ 08540.
ANDA 076045 ........ Lorazepam Tablets USP, 0.5 mg, 1 mg, and 2 mg .............. Do.
ANDA 078055 ........ Zolpidem Tartrate Tablets USP, 5 mg and 10 mg ................ Do.
ANDA 090018 ........ Zoledronic Acid for Injection, Equivalent to 4 mg base/vial .. Sun Pharma Global FZE, c/o Sun Pharmaceutical Indus-
tries, Inc., 2 Independence Way, Princeton, NJ 08540.
Therefore, approval of the we) is announcing the following public mail/hand delivery/courier (for written/
applications listed in the table, and all meeting entitled ‘‘Patient-Focused Drug paper submissions) will be considered
amendments and supplements thereto, Development on Opioid Use Disorder.’’ timely if they are postmarked or the
is hereby withdrawn as of April 13, The purpose of the public meeting is to delivery service acceptance receipt is on
2018. Introduction or delivery for obtain patients’ perspectives on the or before that date.
introduction into interstate commerce of impacts of and treatment approaches for
products without approved new drug Electronic Submissions
opioid use disorder (OUD). This
applications violates section 301(a) and meeting is a part of FDA’s ongoing work Submit electronic comments in the
(d) of the Federal Food, Drug, and aimed at reducing the impact of opioid following way:
Cosmetic Act (21 U.S.C. 331(a) and (d)). abuse and addiction. • Federal eRulemaking Portal:
Drug products that are listed in the table https://www.regulations.gov. Follow the
DATES: The public meeting will be held
that are in inventory on April 13, 2018 instructions for submitting comments.
on April 17, 2018, from 10 a.m. to 4
may continue to be dispensed until the Comments submitted electronically,
p.m. Submit either electronic or written
inventories have been depleted or the including attachments, to https://
comments on this public meeting by
drug products have reached their www.regulations.gov will be posted to
June 18, 2018. See the SUPPLEMENTARY
expiration dates or otherwise become the docket unchanged. Because your
INFORMATION section for registration date
violative, whichever occurs first. comment will be made public, you are
and information.
Dated: March 8, 2018. solely responsible for ensuring that your
ADDRESSES: The public meeting will be comment does not include any
Leslie Kux, held at FDA’s White Oak Campus, confidential information that you or a
Associate Commissioner for Policy. 10903 New Hampshire Ave., Bldg. 31 third party may not wish to be posted,
[FR Doc. 2018–05120 Filed 3–13–18; 8:45 am] Conference Center, the Great Room (Rm. such as medical information, your or
BILLING CODE 4164–01–P 1503), Silver Spring, MD 20993. anyone else’s Social Security number, or
Entrance for the public meeting confidential business information, such
participants (non-FDA employees) is as a manufacturing process. Please note
DEPARTMENT OF HEALTH AND through Building 1 where routine that if you include your name, contact
HUMAN SERVICES security check procedures will be information, or other information that
performed. For parking and security identifies you in the body of your
Food and Drug Administration information, please refer to https:// comments, that information will be
[Docket No. FDA–2018–N–0987] www.fda.gov/AboutFDA/Workingat posted on https://www.regulations.gov.
FDA/BuildingsandFacilities/WhiteOak • If you want to submit a comment
Patient-Focused Drug Development on CampusInformation/ucm241740.htm. with confidential information that you
Opioid Use Disorder; Public Meeting; You may submit comments as do not wish to be made available to the
Request for Comments follows. Please note that late, untimely public, submit the comment as a
daltland on DSKBBV9HB2PROD with NOTICES
AGENCY: Food and Drug Administration, filed comments will not be considered. written/paper submission and in the
HHS. Electronic comments must be submitted manner detailed (see ‘‘Written/Paper
ACTION: Notice of public meeting; on or before June 18, 2018. The https:// Submissions’’ and ‘‘Instructions’’).
request for comments. www.regulations.gov electronic filing
system will accept comments until Written/Paper Submissions
SUMMARY: The Food and Drug midnight Eastern Time at the end of Submit written/paper submissions as
Administration (FDA, the Agency, or June 18, 2018. Comments received by follows:
VerDate Sep<11>2014 18:17 Mar 13, 2018 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1](https://thefederalregister.org/doc/83_FR_11258/page/1.svg)
Document Created: 2018-03-14 01:06:38
Document Modified: 2018-03-14 01:06:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Approval is withdrawn as of April 13, 2018. | |
| 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] | |
| FR Citation | 83 FR 11208 |
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