83 FR 15577 - Oxford Pharmaceuticals, LLC, et al.; Withdrawal of Approval of 18 Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 70 (April 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 70 (April 11, 2018)
| Page Range | 15577-15578 | |
| FR Document | 2018-07440 |
[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)] [Notices] [Pages 15577-15578] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07440] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1336] Oxford Pharmaceuticals, LLC, et al.; Withdrawal of Approval of 18 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 18 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of May 11, 2018.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 040252.............. Carisoprodol and Oxford Aspirin Tablets USP, Pharmaceuticals, 200 milligrams (mg)/ LLC, 301 Leaf Lake 325 mg. Pkwy., Birmingham, AL 35211. ANDA 040283.............. Carisoprodol, Aspirin, Do. and Codeine Phosphate Tablets USP, 200 mg/ 325 mg/16 mg. ANDA 061214.............. Tetracycline Roxane Laboratories, Hydrochloride (HCl) Inc., 1809 Wilson Capsules USP, 250 mg Rd., Columbus, OH and 500 mg. 43228. ANDA 061682.............. Tetracycline HCl Mylan Pharmaceuticals Tablets, 500 mg. Inc., P.O. Box 4293, Morgantown, WV 26505. ANDA 062212.............. Totacillin (ampicillin/ GlaxoSmithKline, Five ampicillin Moore Dr., P.O. Box trihydrate) Capsules, 13398, Research Equivalent to (EQ) Triangle Park, NC 250 mg base and EQ 27709. 500 mg base. ANDA 062654.............. Rocephin (ceftriaxone Hoffman La-Roche, sodium) for Inc., c/o Genentech, Injection, EQ 500 mg Inc., 1 DNA Way, MS base/vial, EQ 1 gram 241B, South San (g) base/vial, and EQ Francisco, CA 94080. 2 g base/vial. ANDA 062680.............. Oxacillin Sodium for ACS Dobfar S.p.A., c/ Injection (Pharmacy o Interchem Corp., Bulk Package). 120 Route 17 North, Paramus, NJ 07653. ANDA 065124.............. Cefotaxime for Lupin Ltd., c/o Lupin Injection USP, EQ 500 Pharmaceuticals, mg base/vial, EQ 1 g Inc., 111 South base/vial, and EQ 2 g Calvert St., base/vial. Harborplace Tower, 24th Floor, Baltimore, MD 21202. ANDA 065263.............. Ceftriaxone for Do. Injection USP, EQ 10 g base/vial (Pharmacy Bulk Package). ANDA 074845.............. Diltiazem HCl Extended- Biovail Corp. Release Capsules USP, International, 60 mg, 90 mg, and 120 Subsidiary of mg. Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. [[Page 15578]] ANDA 077173.............. Ondansetron Injection Sun Pharmaceutical USP, EQ 2 mg base/ Industries Ltd., c/o milliliter (mL). Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. ANDA 078598.............. Ciprofloxacin Amring Ophthalmic Solution Pharmaceuticals, USP, EQ 0.3% base. Inc., 1235 Westlakes Dr., Suite 205, Berwyn, PA 19312. ANDA 078805.............. Irinotecan HCl Sun Pharma Global Injection, 20 mg/mL. FZE, c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. ANDA 086024.............. Capital and Codeine Valeant (acetaminophen and Pharmaceuticals codeine phosphate) North America, LLC, Oral Suspension USP, 400 Somerset 120 mg/12 mg per 5 mL. Corporate Blvd., Bridgewater, NJ 08807. ANDA 091180.............. Dorzolamide HCl and Zambon S.p.A., c/o Timolol Maleate Camargo Ophthalmic Solution, Pharmaceutical EQ 2% base/EQ 0.5% Services, LLC, 9825 base. Kenwood Rd., Suite 203, Cincinnati, OH 45242. ANDA 203176.............. Nevirapine Tablets Technology Organized, USP, 200 mg. LLC, 9191 Point Replete Dr., Fort Belvoir, VA 22060. ANDA 204900.............. Amlodipine Besylate Sovereign Tablets USP, EQ 2.5 Pharmaceuticals, mg base, EQ 5 mg LLC, 7590 Sand St., base, and EQ 10 mg Fort Worth, TX base. 76118. ANDA 209480.............. Clozapine Tablets USP, Zydus Pharmaceuticals 25 mg, 50 mg, 100 mg, USA, Inc., 73 Route and 200 mg. 31 North, Pennington, NJ 08534. ------------------------------------------------------------------------ Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of May 11, 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 May 11, 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: April 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-07440 Filed 4-10-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices 15577
associations and public advocacy Requests for Oral Presentations: If you ACTION: Notice.
groups. Currently, the ICCR members wish to make an oral presentation, you
are: The Brazilian Health Surveillance should notify Jonathan Hicks by May SUMMARY: The Food and Drug
Agency; Health Canada; the European 24, 2018, and submit a brief statement Administration (FDA or Agency) is
Commission Directorate-General for of the general nature of the evidence or withdrawing approval of 18 abbreviated
Internal Market, Industry, arguments that you wish to present, new drug applications (ANDAs) from
Entrepreneurship, and Small and your name, title, affiliation, address, multiple applicants. The holders of the
Medium-sized Enterprises; the Ministry email, and telephone, and indicate the applications notified the Agency in
of Health, Labor, and Welfare of Japan; approximate amount of time you need writing that the drug products were no
and FDA. All decisions are made by to make your presentation. You may
longer marketed and requested that the
consensus and will be compatible with present proposals for future ICCR
agenda items, data, information, or approval of the applications be
the laws, policies, rules, regulations,
views, in person or in writing, on issues withdrawn.
and directives of the respective
administrations and governments. pending at the public meeting. There DATES:Approval is withdrawn as of
Members will implement and/or will be no presentations by phone. Time May 11, 2018.
promote actions or documents within allotted for oral presentations may be
their own jurisdictions and seek limited to 10 minutes or less for each FOR FURTHER INFORMATION CONTACT:
convergence of regulatory policies and presenter, depending on the number of Trang Tran, Center for Drug Evaluation
practices. Successful implementation requests received. and Research, Food and Drug
will need input from stakeholders. Transcripts: Please be advised that as Administration, 10903 New Hampshire
soon as a transcript of the public Ave., Bldg. 75, Rm. 1671, Silver Spring,
II. Topics for Discussion at the Public meeting is available, it will be accessible MD 20993–0002, 240–402–7945,
Meeting at https://www.regulations.gov. It may Trang.Tran@fda.hhs.gov.
also be viewed at the Dockets
We will make the agenda for the Management Staff (HFA–305), Food and SUPPLEMENTARY INFORMATION: The
public meeting available on the internet Drug Administration, 5630 Fishers holders of the applications listed in the
at https://www.fda.gov/Cosmetics/ Lane, Rm. 1061, Rockville, MD 20850. table have informed FDA that these drug
InternationalActivities/ICCR/ products are no longer marketed and
default.htm. Depending on the number Dated: April 5, 2018.
Leslie Kux, have requested that FDA withdraw
of requests for oral presentations, we approval of the applications under the
intend to have an agenda available by Associate Commissioner for Policy.
process in § 314.150(c) (21 CFR
May 31, 2018. [FR Doc. 2018–07416 Filed 4–10–18; 8:45 am]
314.150(c)). The applicants have also,
BILLING CODE 4164–01–P
III. Participating in the Public Meeting by their requests, waived their
opportunity for a hearing. Withdrawal
Registration: To register for the public of approval of an application or
DEPARTMENT OF HEALTH AND
meeting, send registration information abbreviated application under
HUMAN SERVICES
(including your name, title, affiliation, § 314.150(c) is without prejudice to
address, email, and telephone), to Food and Drug Administration refiling.
Jonathan Hicks by May 24, 2018 (see
FOR FURTHER INFORMATION CONTACT). If [Docket No. FDA–2018–N–1336]
you would like to listen to the meeting
Oxford Pharmaceuticals, LLC, et al.;
by phone, please submit a request for a
Withdrawal of Approval of 18
dial-in number by May 24, 2018. If you
Abbreviated New Drug Applications
need special accommodations due to a
disability, please contact Jonathan Hicks AGENCY: Food and Drug Administration,
by May 31, 2018. HHS.
Application No. Drug Applicant
ANDA 040252 ........ Carisoprodol and Aspirin Tablets USP, 200 milligrams (mg)/ Oxford Pharmaceuticals, LLC, 301 Leaf Lake Pkwy., Bir-
325 mg. mingham, AL 35211.
ANDA 040283 ........ Carisoprodol, Aspirin, and Codeine Phosphate Tablets USP, Do.
200 mg/325 mg/16 mg.
ANDA 061214 ........ Tetracycline Hydrochloride (HCl) Capsules USP, 250 mg Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH
and 500 mg. 43228.
ANDA 061682 ........ Tetracycline HCl Tablets, 500 mg .......................................... Mylan Pharmaceuticals Inc., P.O. Box 4293, Morgantown,
WV 26505.
ANDA 062212 ........ Totacillin (ampicillin/ampicillin trihydrate) Capsules, Equiva- GlaxoSmithKline, Five Moore Dr., P.O. Box 13398, Re-
lent to (EQ) 250 mg base and EQ 500 mg base. search Triangle Park, NC 27709.
ANDA 062654 ........ Rocephin (ceftriaxone sodium) for Injection, EQ 500 mg Hoffman La-Roche, Inc., c/o Genentech, Inc., 1 DNA Way,
base/vial, EQ 1 gram (g) base/vial, and EQ 2 g base/vial. MS 241B, South San Francisco, CA 94080.
ANDA 062680 ........ Oxacillin Sodium for Injection (Pharmacy Bulk Package) ..... ACS Dobfar S.p.A., c/o Interchem Corp., 120 Route 17
North, Paramus, NJ 07653.
ANDA 065124 ........ Cefotaxime for Injection USP, EQ 500 mg base/vial, EQ 1 g Lupin Ltd., c/o Lupin Pharmaceuticals, Inc., 111 South Cal-
amozie on DSK30RV082PROD with NOTICES
base/vial, and EQ 2 g base/vial. vert St., Harborplace Tower, 24th Floor, Baltimore, MD
21202.
ANDA 065263 ........ Ceftriaxone for Injection USP, EQ 10 g base/vial (Pharmacy Do.
Bulk Package).
ANDA 074845 ........ Diltiazem HCl Extended-Release Capsules USP, 60 mg, 90 Biovail Corp. International, Subsidiary of Valeant Pharma-
mg, and 120 mg. ceuticals North America, LLC, 400 Somerset Corporate
Blvd., Bridgewater, NJ 08807.
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![15578 Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices
Application No. Drug Applicant
ANDA 077173 ........ Ondansetron Injection USP, EQ 2 mg base/milliliter (mL) .... Sun Pharmaceutical Industries Ltd., c/o Sun Pharmaceutical
Industries, Inc., 2 Independence Way, Princeton, NJ
08540.
ANDA 078598 ........ Ciprofloxacin Ophthalmic Solution USP, EQ 0.3% base ....... Amring Pharmaceuticals, Inc., 1235 Westlakes Dr., Suite
205, Berwyn, PA 19312.
ANDA 078805 ........ Irinotecan HCl Injection, 20 mg/mL ........................................ Sun Pharma Global FZE, c/o Sun Pharmaceutical Indus-
tries, Inc., 2 Independence Way, Princeton, NJ 08540.
ANDA 086024 ........ Capital and Codeine (acetaminophen and codeine phos- Valeant Pharmaceuticals North America, LLC, 400 Som-
phate) Oral Suspension USP, 120 mg/12 mg per 5 mL. erset Corporate Blvd., Bridgewater, NJ 08807.
ANDA 091180 ........ Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, Zambon S.p.A., c/o Camargo Pharmaceutical Services,
EQ 2% base/EQ 0.5% base. LLC, 9825 Kenwood Rd., Suite 203, Cincinnati, OH
45242.
ANDA 203176 ........ Nevirapine Tablets USP, 200 mg .......................................... Technology Organized, LLC, 9191 Point Replete Dr., Fort
Belvoir, VA 22060.
ANDA 204900 ........ Amlodipine Besylate Tablets USP, EQ 2.5 mg base, EQ 5 Sovereign Pharmaceuticals, LLC, 7590 Sand St., Fort
mg base, and EQ 10 mg base. Worth, TX 76118.
ANDA 209480 ........ Clozapine Tablets USP, 25 mg, 50 mg, 100 mg, and 200 Zydus Pharmaceuticals USA, Inc., 73 Route 31 North, Pen-
mg. nington, NJ 08534.
Therefore, approval of the requesting that any consumer and consumer representative
applications listed in the table, and all organizations interested in participating nominations should be submitted
amendments and supplements thereto, in the selection of voting and/or electronically to ACOMSSubmissions@
is hereby withdrawn as of May 11, 2018. nonvoting consumer representatives to fda.hhs.gov, by mail or delivery service
Introduction or delivery for introduction serve on its advisory committees or to Advisory Committee Oversight and
into interstate commerce of products panels notify FDA in writing. FDA is Management Staff, 10903 New
without approved new drug also requesting nominations for voting Hampshire Ave., Bldg. 32, Rm. 5103,
applications violates section 301(a) and and/or nonvoting consumer Silver Spring, MD 20993–0002, or by
(d) of the Federal Food, Drug, and representatives to serve on advisory Fax: 301–847–8640.
Cosmetic Act (21 U.S.C. 331(a) and (d)). committees and/or panels for which Consumer representative nominations
Drug products that are listed in the table vacancies currently exist or are expected should be submitted electronically by
that are in inventory on May 11, 2018 to occur in the near future. Nominees logging into the FDA Advisory
may continue to be dispensed until the recommended to serve as a voting or Committee Membership Nomination
inventories have been depleted or the nonvoting consumer representative may Portal: https://www.accessdata.fda.gov/
drug products have reached their be self-nominated or may be nominated scripts/FACTRSPortal/FACTRS/
expiration dates or otherwise become by a consumer organization. index.cfm; by mail or delivery service to
violative, whichever occurs first. FDA seeks to include the views of
Advisory Committee Oversight and
women and men, members of all racial
Dated: April 5, 2018. Management Staff, 10903 New
and ethnic groups, and individuals with
Leslie Kux, Hampshire Ave., Bldg. 32, Rm. 5103,
and without disabilities on its advisory
Associate Commissioner for Policy. Silver Spring, MD 20993–0002; or by
committees, and therefore encourages
Fax: 301–847–8640. Additional
[FR Doc. 2018–07440 Filed 4–10–18; 8:45 am] nominations of appropriately qualified
information about becoming a member
BILLING CODE 4164–01–P candidates from these groups.
of an FDA advisory committee can also
DATES: Any consumer organization
be obtained by visiting FDA’s website at
interested in participating in the https://www.fda.gov/
DEPARTMENT OF HEALTH AND selection of an appropriate voting or
HUMAN SERVICES AdvisoryCommittees/default.htm.
nonvoting member to represent
consumer interests on an FDA advisory FOR FURTHER INFORMATION CONTACT: For
Food and Drug Administration questions relating to participation in the
committee or panel may send a letter or
[Docket No. FDA–2018–N–1095] email stating that interest to FDA (see selection process: Kimberly Hamilton,
ADDRESSES) by May 11, 2018, for Advisory Committee Oversight and
Request for Nominations for vacancies listed in this notice. Management Staff (ACOMS), Food and
Individuals and Consumer Concurrently, nomination materials for Drug Administration, 10903 New
Organizations for Advisory prospective candidates should be sent to Hampshire Ave., Bldg. 32, Rm. 5103,
Committees FDA (see ADDRESSES) by May 11, 2018. Silver Spring, MD 20993–0002, 301–
AGENCY: Food and Drug Administration, Nominations will be accepted for 796–8220, email: kimberly.hamilton@
HHS. current vacancies and for those that will fda.hhs.gov.
ACTION: Notice. or may occur through July 31, 2018. For questions relating to specific
ADDRESSES: All statements of interest advisory committees or panels, contact
SUMMARY: The Food and Drug from consumer organizations interested the appropriate contact person listed in
Administration (FDA or Agency) is in participating in the selection process table 1.
amozie on DSK30RV082PROD with NOTICES
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Document Created: 2018-04-10 23:59:36
Document Modified: 2018-04-10 23:59:36
| 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 May 11, 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 15577 |
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