83 FR 49102 - GlaxoSmithKline, LLC, et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 189 (September 28, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 189 (September 28, 2018)
| Page Range | 49102-49103 | |
| FR Document | 2018-21199 |
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)] [Notices] [Pages 49102-49103] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21199] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3569] GlaxoSmithKline, LLC, 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 new drug applications (ANDAs) from multiple applicants. The applicants 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of October 29, 2018.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 applicants 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 described 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 061336............ Bactocill (oxacillin GlaxoSmithKline, LLC, sodium) Capsules, Five Moore Dr., P.O. Equivalent to (EQ) 250 Box 13398, Research milligrams (mg) base Triangle Park, NC and EQ 500 mg base. 27709. ANDA 061773............ Kefzol (cefazolin) for ACS Dobfar S.p.A., c/o Injection USP, EQ 250 Interchem Corp., 120 mg base/vial, EQ 500 Rte. 17 North, mg base/vial, EQ 1 Paramus, NJ 07652. gram (g) base/vial, EQ 10 g base/vial, and EQ 20 g base/vial. ANDA 062615............ Nystatin Vaginal Odyssey Inserts USP, 100,000 Pharmaceuticals, units. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 063304............ Clindamycin Phosphate Wockhardt Bio AG, c/o Topical Solution USP, Morton Grove EQ 1% base. Pharmaceuticals, Inc., 6451 Main St., Morton Grove, IL 60053. ANDA 065001............ Cefuroxime for Fresenius Kabi USA, Injection USP, EQ LLC, Three Corporate 750mg base/vial and EQ Dr., Lake Zurich, IL 1.5 g base/vial. 60047. ANDA 065002............ Cefuroxime for Do. Injection USP, EQ 7.5 g base/vial (Pharmacy Bulk Package). ANDA 070736............ Ibuprofen Tablets USP, Aurolife Pharma, LLC, 300 mg, 400 mg, and 279 Princeton 600 mg. Hightstown Rd., East Windsor, NJ 08520. ANDA 071202............ Sensorcaine--MPF Spinal Fresenius Kabi USA, (bupivacaine LLC. hydrochloride (HCl)) in Dextrose Injection 8.25% USP, 0.75%. ANDA 071846............ Nitroglycerin in Hospira, Inc., 275 Dextrose 5% Injection, North Field Dr., 10 mg/100 milliliter Bldg. H1, Lake (mL). Forest, IL 60045. ANDA 071847............ Nitroglycerin in Do. Dextrose 5% Injection, 20 mg/100 mL. ANDA 071848............ Nitroglycerin in Do. Dextrose 5% Injection, 40 mg/100 mL. ANDA 072629............ Albuterol Tablets USP, Watson Laboratories, EQ 2 mg base. Inc., Subsidiary of Teva Pharmaceuticals USA Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 074991............ Loperamide HCl Oral Duramed Solution, 1 mg/5 mL. Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. [[Page 49103]] ANDA 077312............ Fentanyl Citrate Troche/ Par Pharmaceutical, Lozenge, EQ 0.2 mg Inc., One Ram Ridge base, EQ 0.4 mg base, Rd., Chestnut Ridge, EQ 0.6 mg base, EQ 0.8 NY 10977. mg base, EQ 1.2 mg, and EQ 1.6 mg base. ANDA 077853............ Metformin HCl Tablets Provident USP, 500 mg, 850 mg, Pharmaceutical, Inc., and 1 g. c/o Vintage Pharmaceuticals, LLC, 1400 Atwater Dr., Malvern, PA 19355. ANDA 080355............ Hydrocortisone Tablets Watson Laboratories, USP, 20 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., Morris Corporate Center III, 400 Interpace Pkwy., Parsippany, NJ 07054. ANDA 080377............ Lidocaine HCl with Watson Laboratories, Epinephrine Injection, Inc., Subsidiary of 1%; 0.01 mg/mL and 2%; Teva Pharmaceuticals 0.01 mg/mL. USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 087100............ Chlorthalidone Tablets Do. USP, 25 mg. ANDA 087211............ Methocarbamol and Ivax Pharmaceuticals, Aspirin Tablets, 400 Inc., Subsidiary of mg/325 mg. Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 090184............ Podofilox Topical Bausch & Lomb, Inc., Solution, 0.5%. Subsidiary of Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. ANDA 202002............ Imiquimod Cream, 5%.... Strides Pharma Global Pte Ltd., c/o Strides Pharma, Inc., 2 Tower Center Blvd., Suite 1102, East Brunswick, NJ 08816. ANDA 203247............ Sodium Fluoride F-18 University of Texas MD Injection, 10-200 Anderson Cancer millicurie (mCi)/mL. Center, Cyclotron Radiochemistry Facility, 1881 East Rd., Unit 1903, Houston, TX 77054. ANDA 203933............ Ammonia N-13 Injection, Do. 3.75-37.5 mCi/mL. ANDA 205072............ Cefadroxil Capsules CSPC Ouyi USP, EQ 500 mg base. Pharmaceutical Co., Ltd., c/o Megalith Pharmaceuticals, Inc., 9625 Hillside Rd., Rancho Cucamonga, CA 91737. ------------------------------------------------------------------------ Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of October 29, 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 October 29, 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: September 25, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21199 Filed 9-27-18; 8:45 am] BILLING CODE 4164-01-P
![49102 Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices
person on or before November 1, 2018. Persons attending FDA’s advisory ACTION: Notice.
Oral presentations from the public will committee meetings are advised that the
be scheduled between approximately Agency is not responsible for providing SUMMARY: The Food and Drug
12:45 p.m. to 1:45 p.m. Those access to electrical outlets. Administration (FDA or Agency) is
individuals interested in making formal FDA welcomes the attendance of the withdrawing approval of 24 abbreviated
oral presentations should notify the public at its advisory committee new drug applications (ANDAs) from
contact person and submit a brief meetings and will make every effort to multiple applicants. The applicants
statement of the general nature of the accommodate persons with disabilities. notified the Agency in writing that the
evidence or arguments they wish to If you require accommodations due to a drug products were no longer marketed
present, the names and addresses of disability, please contact Serina Hunter- and requested that the approval of the
proposed participants, and an Thomas at least 7 days in advance of the
indication of the approximate time applications be withdrawn.
meeting.
requested to make their presentation on FDA is committed to the orderly DATES:Approval is withdrawn as of
or before October 24, 2018. Time conduct of its advisory committee October 29, 2018.
allotted for each presentation may be meetings. Please visit our website at:
limited. If the number of registrants FOR FURTHER INFORMATION CONTACT:
https://www.fda.gov/
requesting to speak is greater than can AdvisoryCommittees/AboutAdvisory Trang Tran, Center for Drug Evaluation
be reasonably accommodated during the Committees/ucm111462.htm for and Research, Food and Drug
scheduled open public hearing session, procedures on public conduct during Administration, 10903 New Hampshire
FDA may conduct a lottery to determine advisory committee meetings. Ave., Bldg. 75, Rm. 1671, Silver Spring,
the speakers for the scheduled open Notice of this meeting is given under MD 20993–0002, 240–402–7945,
public hearing session. The contact the Federal Advisory Committee Act (5 Trang.Tran@fda.hhs.gov.
person will notify interested persons U.S.C. app. 2). SUPPLEMENTARY INFORMATION: The
regarding their request to speak by
October 25, 2018.
Dated: September 24, 2018. applicants listed in the table have
Closed Committee Deliberations: On Leslie Kux, informed FDA that these drug products
November 8, 2018, from 1:50 p.m. to Associate Commissioner for Policy. are no longer marketed and have
2:45 p.m., the meeting will be closed to [FR Doc. 2018–21137 Filed 9–27–18; 8:45 am] requested that FDA withdraw approval
permit discussion where disclosure BILLING CODE 4164–01–P of the applications under the process
would constitute a clearly unwarranted described in § 314.150(c) (21 CFR
invasion of personal privacy (5 U.S.C. 314.150(c)). The applicants have also,
552b(c)(6)). The recommendations of the DEPARTMENT OF HEALTH AND by their requests, waived their
advisory committee regarding the HUMAN SERVICES opportunity for a hearing. Withdrawal
progress of the investigator’s research of approval of an application or
will, along with other information, be Food and Drug Administration abbreviated application under
used in making personnel and staffing § 314.150(c) is without prejudice to
[Docket No. FDA–2018–N–3569]
decisions regarding individual refiling.
scientists. GlaxoSmithKline, LLC, et al.;
We believe that public discussion of Withdrawal of Approval of 24
these recommendations on individual Abbreviated New Drug Applications
scientists would constitute an
unwarranted invasion of personal AGENCY: Food and Drug Administration,
privacy. HHS.
Application No. Drug Applicant
ANDA 061336 .... Bactocill (oxacillin sodium) Capsules, Equivalent to (EQ) 250 GlaxoSmithKline, LLC, Five Moore Dr., P.O. Box 13398, Re-
milligrams (mg) base and EQ 500 mg base. search Triangle Park, NC 27709.
ANDA 061773 .... Kefzol (cefazolin) for Injection USP, EQ 250 mg base/vial, ACS Dobfar S.p.A., c/o Interchem Corp., 120 Rte. 17 North,
EQ 500 mg base/vial, EQ 1 gram (g) base/vial, EQ 10 g Paramus, NJ 07652.
base/vial, and EQ 20 g base/vial.
ANDA 062615 .... Nystatin Vaginal Inserts USP, 100,000 units ........................... Odyssey Pharmaceuticals, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 063304 .... Clindamycin Phosphate Topical Solution USP, EQ 1% base Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc.,
6451 Main St., Morton Grove, IL 60053.
ANDA 065001 .... Cefuroxime for Injection USP, EQ 750mg base/vial and EQ Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich,
1.5 g base/vial. IL 60047.
ANDA 065002 .... Cefuroxime for Injection USP, EQ 7.5 g base/vial (Pharmacy Do.
Bulk Package).
ANDA 070736 .... Ibuprofen Tablets USP, 300 mg, 400 mg, and 600 mg .......... Aurolife Pharma, LLC, 279 Princeton Hightstown Rd., East
Windsor, NJ 08520.
ANDA 071202 .... Sensorcaine—MPF Spinal (bupivacaine hydrochloride (HCl)) Fresenius Kabi USA, LLC.
in Dextrose Injection 8.25% USP, 0.75%.
amozie on DSK3GDR082PROD with NOTICES1
ANDA 071846 .... Nitroglycerin in Dextrose 5% Injection, 10 mg/100 milliliter Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL
(mL). 60045.
ANDA 071847 .... Nitroglycerin in Dextrose 5% Injection, 20 mg/100 mL ........... Do.
ANDA 071848 .... Nitroglycerin in Dextrose 5% Injection, 40 mg/100 mL ........... Do.
ANDA 072629 .... Albuterol Tablets USP, EQ 2 mg base .................................... Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 074991 .... Loperamide HCl Oral Solution, 1 mg/5 mL ............................. Duramed Pharmaceuticals, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
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![Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices 49103
Application No. Drug Applicant
ANDA 077312 .... Fentanyl Citrate Troche/Lozenge, EQ 0.2 mg base, EQ 0.4 Par Pharmaceutical, Inc., One Ram Ridge Rd., Chestnut
mg base, EQ 0.6 mg base, EQ 0.8 mg base, EQ 1.2 mg, Ridge, NY 10977.
and EQ 1.6 mg base.
ANDA 077853 .... Metformin HCl Tablets USP, 500 mg, 850 mg, and 1 g ......... Provident Pharmaceutical, Inc., c/o Vintage Pharmaceuticals,
LLC, 1400 Atwater Dr., Malvern, PA 19355.
ANDA 080355 .... Hydrocortisone Tablets USP, 20 mg ....................................... Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc., Morris Corporate Center III, 400
Interpace Pkwy., Parsippany, NJ 07054.
ANDA 080377 .... Lidocaine HCl with Epinephrine Injection, 1%; 0.01 mg/mL Watson Laboratories, Inc., Subsidiary of Teva Pharma-
and 2%; 0.01 mg/mL. ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 087100 .... Chlorthalidone Tablets USP, 25 mg ........................................ Do.
ANDA 087211 .... Methocarbamol and Aspirin Tablets, 400 mg/325 mg ............. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 090184 .... Podofilox Topical Solution, 0.5% ............................................. Bausch & Lomb, Inc., Subsidiary of Valeant Pharmaceuticals
North America, LLC, 400 Somerset Corporate Blvd.,
Bridgewater, NJ 08807.
ANDA 202002 .... Imiquimod Cream, 5% ............................................................. Strides Pharma Global Pte Ltd., c/o Strides Pharma, Inc., 2
Tower Center Blvd., Suite 1102, East Brunswick, NJ
08816.
ANDA 203247 .... Sodium Fluoride F–18 Injection, 10–200 millicurie (mCi)/mL .. University of Texas MD Anderson Cancer Center, Cyclotron
Radiochemistry Facility, 1881 East Rd., Unit 1903, Hous-
ton, TX 77054.
ANDA 203933 .... Ammonia N–13 Injection, 3.75–37.5 mCi/mL .......................... Do.
ANDA 205072 .... Cefadroxil Capsules USP, EQ 500 mg base ........................... CSPC Ouyi Pharmaceutical Co., Ltd., c/o Megalith Pharma-
ceuticals, Inc., 9625 Hillside Rd., Rancho Cucamonga, CA
91737.
Therefore, approval of the names of dairy foods such as ‘‘milk,’’ Electronic Submissions
applications listed in the table, and all ‘‘cultured milk,’’ ‘‘yogurt,’’ and Submit electronic comments in the
amendments and supplements thereto, ‘‘cheese.’’ We are interested in learning following way:
is hereby withdrawn as of October 29, how consumers use these plant-based • Federal eRulemaking Portal:
2018. Introduction or delivery for products and how they understand https://www.regulations.gov. Follow the
introduction into interstate commerce of terms such as, for example, ‘‘milk’’ or instructions for submitting comments.
products without approved new drug ‘‘yogurt’’ when included in the names of
applications violates section 301(a) and Comments submitted electronically,
plant-based products. We also are including attachments, to https://
(d) of the Federal Food, Drug, and interested in learning whether
Cosmetic Act (21 U.S.C. 331(a) and (d)). www.regulations.gov will be posted to
consumers are aware of and understand the docket unchanged. Because your
Drug products that are listed in the table
differences between the basic nature, comment will be made public, you are
that are in inventory on October 29,
2018 may continue to be dispensed characteristics, ingredients, and solely responsible for ensuring that your
until the inventories have been depleted nutritional content of plant-based comment does not include any
or the drug products have reached their products and their dairy counterparts. confidential information that you or a
expiration dates or otherwise become We are taking this action to inform our third party may not wish to be posted,
violative, whichever occurs first. development of an approach to the such as medical information, your or
labeling of plant-based products that anyone else’s Social Security number, or
Dated: September 25, 2018. confidential business information, such
consumers may substitute for dairy
Leslie Kux, as a manufacturing process. Please note
foods.
Associate Commissioner for Policy. that if you include your name, contact
[FR Doc. 2018–21199 Filed 9–27–18; 8:45 am] DATES: Submit either electronic or information, or other information that
BILLING CODE 4164–01–P written comments on this document by identifies you in the body of your
November 27, 2018. comments, that information will be
posted on https://www.regulations.gov.
ADDRESSES: You may submit comments
DEPARTMENT OF HEALTH AND • If you want to submit a comment
HUMAN SERVICES as follows. Please note that late, with confidential information that you
untimely filed comments will not be do not wish to be made available to the
Food and Drug Administration considered. Electronic comments must public, submit the comment as a
[Docket No. FDA–2018–N–3522] be submitted on or before November 27, written/paper submission and in the
2018. The https://www.regulations.gov manner detailed (see ‘‘Written/Paper
Use of the Names of Dairy Foods in the electronic filing system will accept Submissions’’ and ‘‘Instructions’’).
Labeling of Plant-Based Products comments until midnight Eastern Time
at the end of November 27, 2018. Written/Paper Submissions
AGENCY: Food and Drug Administration,
amozie on DSK3GDR082PROD with NOTICES1
HHS. Comments received by mail/hand Submit written/paper submissions as
ACTION: Notice; request for comments. delivery/courier (for written/paper follows:
submissions) will be considered timely • Mail/Hand delivery/Courier (for
SUMMARY: The Food and Drug if they are postmarked or the delivery written/paper submissions): Dockets
Administration (FDA or we) invites service acceptance receipt is on or Management Staff (HFA–305), Food and
comments on the labeling of plant-based before that date. Drug Administration, 5630 Fishers
products with names that include the Lane, Rm. 1061, Rockville, MD 20852.
VerDate Sep<11>2014 19:22 Sep 27, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1](https://thefederalregister.org/doc/83_FR_49291/page/2.svg)
Document Created: 2018-09-28 01:22:46
Document Modified: 2018-09-28 01:22:46
| 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 October 29, 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 49102 |
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