83 FR 32305 - Concordia Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 29 New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 134 (July 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 134 (July 12, 2018)
| Page Range | 32305-32306 | |
| FR Document | 2018-14935 |
[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)] [Notices] [Pages 32305-32306] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-14935] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2180] Concordia Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 29 New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 29 new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of August 13, 2018.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 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 ------------------------------------------------------------------------ NDA 011287............. Kayexalate (sodium Concordia polystyrene sulfonate) Pharmaceuticals, Powder for Suspension, Inc., c/o Mapi USA, 453.6 gram (g)/bottle. Inc., 2343 Alexandria Dr., Lexington, KY 40504. NDA 012249............. Librium Valeant (chlordiazepoxide Pharmaceuticals North hydrochloride (HCl)) America, LLC, 400 Capsules, 5 milligram Somerset Corporate (mg), 10 mg, and 25 mg. Blvd., Bridgewater, NJ 08807. NDA 016211............. Miochol (acetylcholine Novartis chloride) for Pharmaceuticals Ophthalmic Solution, Corp., One Health 20 mg/vial. Pl., East Hanover, NJ 07936. NDA 018674............. Metro I.V. B. Braun Medical, (metronidazole) Inc., 901 Marcon Injection, 500 mg/100 Blvd., Allentown, PA milliliter (mL). 18109. NDA 018852............. Sulfamethoxazole and Watson Laboratories, Trimethoprim Tablets Inc., Subsidiary of USP, 400 mg; 80 mg. Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. NDA 018854............. Sulfamethoxazole and Do. Trimethoprim Tablets USP, 800 mg; 160 mg. NDA 018988............. Vasocidin (prednisolone Novartis sodium phosphate and Pharmaceuticals Corp. sulfacetamide sodium) Ophthalmic Solution, equivalent to (EQ) 0.23% phosphate/10%. NDA 019844............. Isolyte H in Dextrose B. Braun Medical, Inc. 5% in Plastic Container Injection. NDA 019870............. Isolyte M in Dextrose Do. 5% in Plastic Container Injection. NDA 019964............. Terazol 3 (terconazole) Janssen Vaginal Cream, 0.8%. Pharmaceuticals, Inc., 1125 Trenton- Harbourton Rd., Titusville, NJ 08560. NDA 020000............. Dextrose 5% in Ringer's B. Braun Medical, Inc. in Plastic Container Injection. NDA 020393............. Atrovent (ipratropium Boehringer Ingelheim bromide) Nasal Spray, Pharmaceuticals, 0.021 mg/spray. Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877- 0368. NDA 020394............. Atrovent (ipratropium Do. bromide) Nasal Spray, 0.042 mg/spray. NDA 021180............. Ortho Evra (ethinyl Janssen estradiol; Pharmaceuticals, norelgestromin) Inc., 1000 U.S. Route Transdermal Patch, 202, P.O. Box 300, 0.035 mg/24 h; 0.15 mg/ Raritan, NJ 08869- 24 h. 0602. NDA 021633............. Femtrace (estradiol Allergan acetate) Tablets, 0.45 Pharmaceuticals mg, 0.9 mg, and 1.8 mg. International, Ltd., c/o Allergan Sales, LLC, 2525 Dupont Dr., Irvine, CA 92612. NDA 022033............. Luvox CR (fluvoxamine Jazz Pharmaceuticals, maleate) Extended- Inc., 3180 Porter Release Capsules, 100 Dr., Palo Alto, CA mg and 150 mg. 94304. NDA 022106............. Doribax (doripenem) for Shionogi, Inc., 300 Injection, 250 mg/vial Campus Dr., Florham and 500 mg/vial. Park, NJ 07932. NDA 022386............. PrandiMet (metformin Novo Nordisk, Inc., HCl; repaglinide) P.O. Box 846, Tablets, 500mg; 1 mg Plainsboro, NJ 08536. and 500 mg; 2 mg. NDA 050201............. Ophthocort Parkedale (chloramphenicol, Pharmaceuticals, hydrocortisone Subsidiary of Pfizer acetate, polymyxin B Inc., 235 East 42nd sulfate) Ophthalmic St., New York, NY Ointment USP, 10 mg/g; 10017. 5 mg/g; 10,000 units/g. NDA 050344............. Statrol (neomycin Alcon Laboratories, sulfate; polymyxin B Inc., 6201 South sulfate) Ophthalmic Freeway, TC-45, Fort Ointment, EQ 3.5 mg Worth, TX 76134. base/g; 10,000 units/g. NDA 050442............. Vibramycin (doxycycline Pfizer, Inc., 235 East hyclate) Injection, EQ 42nd St., New York, to 200 mg base/vial NY 10017. and EQ 100 mg base/ vial. NDA 050497............. Ticar (ticarcillin GlaxoSmithKline, 1250 disodium) Injection, Collegeville Rd., EQ 1 g base/vial, EQ 3 Collegeville, PA g base/vial, EQ 6 g 19426. base/vial, EQ 20 g base/vial, and EQ 30 g base/vial. NDA 050512............. Duricef (cefadroxil Warner Chilcott Co., monohydrate) USP LLC, 100 Enterprise Capsules, EQ 500 mg Dr., Rockaway, NJ base and EQ 250 mg 07866. base. NDA 050527............. Duricef (cefadroxil Do. monohydrate) USP For Oral Suspension, EQ 125 mg base/5 mL, EQ 250 mg base/5 mL, and EQ 500 mg base/5 mL. NDA 050593............. Eryc Sprinkles Hospira Inc., 275 (erythromycin) North Field Dr., Lake Capsules, 125 mg. Forest, IL 60045. NDA 050646............. Ceptaz (ceftazidime) GlaxoSmithKline. Injection, 500 mg/ vial, 1 g/vial, 2 g/ vial, and 10 g/vial. NDA 050668............. Lorabid (loracarbef) King Pharmaceuticals, Capsules USP, 200 mg Inc., 501 Fifth St., and 400 mg. Bristol, TN 37620. NDA 050792............. Cefotaxime and Dextrose B. Braun Medical, Inc. 2.4% in Plastic Container, EQ 2 g base, and Cefotaxime and Dextrose 3.9% in Plastic Container, EQ 1 g base. [[Page 32306]] NDA 050807............. Epirubicin HCl for Hospira, Inc. Injection, 50 mg/vial, 200 mg/vial. ------------------------------------------------------------------------ Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of August 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 August 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: July 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-14935 Filed 7-11-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 32305
collections of information in 21 CFR Dated: July 5, 2018. longer marketed and requested that the
part 58 have been approved under OMB Leslie Kux, approval of the applications be
control number 0910–0119; the Associate Commissioner for Policy. withdrawn.
collections of information in 21 CFR [FR Doc. 2018–14871 Filed 7–11–18; 8:45 am]
part 312 have been approved under DATES:Approval is withdrawn as of
BILLING CODE 4164–01–P
OMB control number 0910–0014; the August 13, 2018.
collections of information in 21 CFR FOR FURTHER INFORMATION CONTACT:
part 601 have been approved under DEPARTMENT OF HEALTH AND Florine P. Purdie, Center for Drug
OMB control number 0910–0338; the HUMAN SERVICES Evaluation and Research, Food and
collections of information in the Drug Administration, 10903 New
guidance entitled ‘‘Expedited Programs Food and Drug Administration Hampshire Ave., Bldg. 51, Rm. 6248,
for Serious Conditions—Drugs and Silver Spring, MD 20993–0002, 301–
[Docket No. FDA–2018–N–2180]
Biologics’’ have been approved under 796–3601.
OMB control number 0910–0765; and Concordia Pharmaceuticals, Inc., et al.;
the collections of information in the SUPPLEMENTARY INFORMATION: The
Withdrawal of Approval of 29 New
guidance entitled ‘‘Formal Meetings holders of the applications listed in the
Drug Applications
Between the FDA and Sponsors or table have informed FDA that these drug
Applicants’’ have been approved under AGENCY: Food and Drug Administration, products are no longer marketed and
OMB control number 0910–0429. HHS. have requested that FDA withdraw
ACTION: Notice. approval of the applications under the
III. Electronic Access process in § 314.150(c) (21 CFR
Persons with access to the internet SUMMARY: The Food and Drug 314.150(c)). The applicants have also,
may obtain the draft guidance at either Administration (FDA or Agency) is by their requests, waived their
https://www.fda.gov/BiologicsBlood withdrawing approval of 29 new drug opportunity for a hearing. Withdrawal
Vaccines/GuidanceCompliance applications (NDAs) from multiple of approval of an application or
RegulatoryInformation/Guidances/ applicants. The holders of the abbreviated application under
default.htm or https:// applications notified the Agency in § 314.150(c) is without prejudice to
www.regulations.gov. writing that the drug products were no refiling.
Application No. Drug Applicant
NDA 011287 ......... Kayexalate (sodium polystyrene sulfonate) Powder for Suspension, Concordia Pharmaceuticals, Inc., c/o Mapi USA, Inc., 2343 Alexandria
453.6 gram (g)/bottle. Dr., Lexington, KY 40504.
NDA 012249 ......... Librium (chlordiazepoxide hydrochloride (HCl)) Capsules, 5 milligram Valeant Pharmaceuticals North America, LLC, 400 Somerset Cor-
(mg), 10 mg, and 25 mg. porate Blvd., Bridgewater, NJ 08807.
NDA 016211 ......... Miochol (acetylcholine chloride) for Ophthalmic Solution, 20 mg/vial .... Novartis Pharmaceuticals Corp., One Health Pl., East Hanover, NJ
07936.
NDA 018674 ......... Metro I.V. (metronidazole) Injection, 500 mg/100 milliliter (mL) ............. B. Braun Medical, Inc., 901 Marcon Blvd., Allentown, PA 18109.
NDA 018852 ......... Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg; 80 mg ...... Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA,
Inc., 425 Privet Rd., Horsham, PA 19044.
NDA 018854 ......... Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg; 160 mg .... Do.
NDA 018988 ......... Vasocidin (prednisolone sodium phosphate and sulfacetamide sodium) Novartis Pharmaceuticals Corp.
Ophthalmic Solution, equivalent to (EQ) 0.23% phosphate/10%.
NDA 019844 ......... Isolyte H in Dextrose 5% in Plastic Container Injection ......................... B. Braun Medical, Inc.
NDA 019870 ......... Isolyte M in Dextrose 5% in Plastic Container Injection ......................... Do.
NDA 019964 ......... Terazol 3 (terconazole) Vaginal Cream, 0.8% ........................................ Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd.,
Titusville, NJ 08560.
NDA 020000 ......... Dextrose 5% in Ringer’s in Plastic Container Injection .......................... B. Braun Medical, Inc.
NDA 020393 ......... Atrovent (ipratropium bromide) Nasal Spray, 0.021 mg/spray ............... Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O.
Box 368, Ridgefield, CT 06877–0368.
NDA 020394 ......... Atrovent (ipratropium bromide) Nasal Spray, 0.042 mg/spray ............... Do.
NDA 021180 ......... Ortho Evra (ethinyl estradiol; norelgestromin) Transdermal Patch, Janssen Pharmaceuticals, Inc., 1000 U.S. Route 202, P.O. Box 300,
0.035 mg/24 h; 0.15 mg/24 h. Raritan, NJ 08869–0602.
NDA 021633 ......... Femtrace (estradiol acetate) Tablets, 0.45 mg, 0.9 mg, and 1.8 mg ..... Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC,
2525 Dupont Dr., Irvine, CA 92612.
NDA 022033 ......... Luvox CR (fluvoxamine maleate) Extended-Release Capsules, 100 mg Jazz Pharmaceuticals, Inc., 3180 Porter Dr., Palo Alto, CA 94304.
and 150 mg.
NDA 022106 ......... Doribax (doripenem) for Injection, 250 mg/vial and 500 mg/vial ............ Shionogi, Inc., 300 Campus Dr., Florham Park, NJ 07932.
NDA 022386 ......... PrandiMet (metformin HCl; repaglinide) Tablets, 500mg; 1 mg and 500 Novo Nordisk, Inc., P.O. Box 846, Plainsboro, NJ 08536.
mg; 2 mg.
NDA 050201 ......... Ophthocort (chloramphenicol, hydrocortisone acetate, polymyxin B sul- Parkedale Pharmaceuticals, Subsidiary of Pfizer Inc., 235 East 42nd
fate) Ophthalmic Ointment USP, 10 mg/g; 5 mg/g; 10,000 units/g. St., New York, NY 10017.
NDA 050344 ......... Statrol (neomycin sulfate; polymyxin B sulfate) Ophthalmic Ointment, Alcon Laboratories, Inc., 6201 South Freeway, TC–45, Fort Worth, TX
EQ 3.5 mg base/g; 10,000 units/g. 76134.
NDA 050442 ......... Vibramycin (doxycycline hyclate) Injection, EQ to 200 mg base/vial Pfizer, Inc., 235 East 42nd St., New York, NY 10017.
and EQ 100 mg base/vial.
NDA 050497 ......... Ticar (ticarcillin disodium) Injection, EQ 1 g base/vial, EQ 3 g base/ GlaxoSmithKline, 1250 Collegeville Rd., Collegeville, PA 19426.
vial, EQ 6 g base/vial, EQ 20 g base/vial, and EQ 30 g base/vial.
NDA 050512 ......... Duricef (cefadroxil monohydrate) USP Capsules, EQ 500 mg base and Warner Chilcott Co., LLC, 100 Enterprise Dr., Rockaway, NJ 07866.
amozie on DSK3GDR082PROD with NOTICES1
EQ 250 mg base.
NDA 050527 ......... Duricef (cefadroxil monohydrate) USP For Oral Suspension, EQ 125 Do.
mg base/5 mL, EQ 250 mg base/5 mL, and EQ 500 mg base/5 mL.
NDA 050593 ......... Eryc Sprinkles (erythromycin) Capsules, 125 mg ................................... Hospira Inc., 275 North Field Dr., Lake Forest, IL 60045.
NDA 050646 ......... Ceptaz (ceftazidime) Injection, 500 mg/vial, 1 g/vial, 2 g/vial, and 10 g/ GlaxoSmithKline.
vial.
NDA 050668 ......... Lorabid (loracarbef) Capsules USP, 200 mg and 400 mg ..................... King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620.
NDA 050792 ......... Cefotaxime and Dextrose 2.4% in Plastic Container, EQ 2 g base, and B. Braun Medical, Inc.
Cefotaxime and Dextrose 3.9% in Plastic Container, EQ 1 g base.
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![32306 Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
Application No. Drug Applicant
NDA 050807 ......... Epirubicin HCl for Injection, 50 mg/vial, 200 mg/vial .............................. Hospira, Inc.
Therefore, approval of the Agency considers your comment on this a.m. and 4 p.m., Monday through
applications listed in the table, and all draft guidance before it begins work on Friday.
amendments and supplements thereto, the final version of the guidance. • Confidential Submissions—To
is hereby withdrawn as of August 13, ADDRESSES: You may submit comments submit a comment with confidential
2018. Introduction or delivery for on any guidance at any time as follows: information that you do not wish to be
introduction into interstate commerce of made publicly available, submit your
products without approved new drug Electronic Submissions comments only as a written/paper
applications violates section 301(a) and Submit electronic comments in the submission. You should submit two
(d) of the Federal Food, Drug, and following way: copies, total. One copy will include the
Cosmetic Act (21 U.S.C. 331(a) and (d)). • Federal eRulemaking Portal: information you claim to be confidential
Drug products that are listed in the table https://www.regulations.gov. Follow the with a heading or cover note that states
that are in inventory on August 13, 2018 instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS
may continue to be dispensed until the Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ The
inventories have been depleted or the Agency will review this copy, including
including attachments, to https://
drug products have reached their the claimed confidential information, in
www.regulations.gov will be posted to
expiration dates or otherwise become its consideration of comments. The
the docket unchanged. Because your
violative, whichever occurs first. second copy, which will have the
comment will be made public, you are
claimed confidential information
Dated: July 9, 2018. solely responsible for ensuring that your
redacted/blacked out, will be available
Leslie Kux, comment does not include any
for public viewing and posted on
Associate Commissioner for Policy. confidential information that you or a
https://www.regulations.gov. Submit
third party may not wish to be posted,
[FR Doc. 2018–14935 Filed 7–11–18; 8:45 am] both copies to the Dockets Management
such as medical information, your or
BILLING CODE 4164–01–P Staff. If you do not wish your name and
anyone else’s Social Security number, or contact information to be made publicly
confidential business information, such available, you can provide this
DEPARTMENT OF HEALTH AND as a manufacturing process. Please note information on the cover sheet and not
HUMAN SERVICES that if you include your name, contact in the body of your comments, and you
information, or other information that must identify this information as
Food and Drug Administration identifies you in the body of your ‘‘confidential.’’ Any information marked
comments, that information will be as ‘‘confidential’’ will not be disclosed
[Docket No. FDA 2018–D–2238]
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
Human Gene Therapy for Hemophilia; • If you want to submit a comment and other applicable disclosure law. For
Draft Guidance for Industry; with confidential information that you more information about FDA’s posting
Availability do not wish to be made available to the of comments to public dockets, see 80
public, submit the comment as a FR 56469, September 18, 2015, or access
AGENCY: Food and Drug Administration, written/paper submission and in the the information at: https://www.gpo.gov/
HHS. manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
ACTION: Notice of availability. Submissions’’ and ‘‘Instructions’’). 23389.pdf.
Written/Paper Submissions Docket: For access to the docket to
SUMMARY: The Food and Drug
read background documents or the
Administration (FDA or Agency) is Submit written/paper submissions as electronic and written/paper comments
announcing the availability of a draft follows: received, go to https://
document entitled ‘‘Human Gene • Mail/Hand Delivery/Courier (for www.regulations.gov and insert the
Therapy for Hemophilia; Draft Guidance Written/Paper Submissions): Dockets docket number, found in brackets in the
for Industry.’’ The draft guidance Management Staff (HFA–305), Food and heading of this document, into the
document provides recommendations to Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
stakeholders developing human gene Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
therapy (GT) products for the treatment • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
of hemophilia. The draft guidance submitted to the Dockets Management Rockville, MD 20852.
provides recommendations on the Staff, FDA will post your comment as You may submit comments on any
clinical trial design and related well as any attachments, except for guidance at any time (see 21 CFR
development of coagulation factor VIII information submitted, marked, and 10.115(g)(5)).
(hemophilia A) and IX (hemophilia B) identified as confidential, if submitted Submit written requests for single
activity assays, including how to as detailed in ‘‘Instructions.’’ copies of the draft guidance to the Office
address discrepancies in factor VIII and Instructions: All submissions received of Communication, Outreach and
factor IX activity assays. The draft must include the Docket No. FDA 2018– Development, Center for Biologics
guidance also includes D–2238 for ‘‘Human Gene Therapy for Evaluation and Research (CBER), Food
amozie on DSK3GDR082PROD with NOTICES1
recommendations regarding preclinical Hemophilia; Draft Guidance for and Drug Administration, 10903 New
considerations to support development Industry.’’ Received comments will be Hampshire Ave., Bldg. 71, Rm. 3128,
of GT products for the treatment of placed in the docket and, except for Silver Spring, MD 20993–0002. Send
hemophilia. those submitted as ‘‘Confidential one self-addressed adhesive label to
DATES: Submit either electronic or Submissions,’’ publicly viewable at assist the office in processing your
written comments on the draft guidance https://www.regulations.gov or at the requests. The draft guidance may also be
by October 10, 2018 to ensure that the Dockets Management Staff between 9 obtained by mail by calling CBER at 1–
VerDate Sep<11>2014 17:21 Jul 11, 2018 Jkt 244001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\12JYN1.SGM 12JYN1](https://thefederalregister.org/doc/83_FR_32439/page/2.svg)
Document Created: 2018-11-06 10:21:58
Document Modified: 2018-11-06 10:21:58
| 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 August 13, 2018. | |
| 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. | |
| FR Citation | 83 FR 32305 |
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