83_FR_40226 83 FR 40070 - Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications

83 FR 40070 - Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 156 (August 13, 2018)

Page Range40070-40071
FR Document2018-17226

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Federal Register, Volume 83 Issue 156 (Monday, August 13, 2018) 
[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Pages 40070-40071]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17226]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2876]


Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 
20 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 20 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requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of September 12, 2018.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 
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 060133.................  Chloramphenicol       Fougera
                               Ophthalmic            Pharmaceuticals,
                               Ointment, 1%.         Inc., 60 Baylis
                                                     Rd., P.O. Box 2006,
                                                     Melville, NY 11747.
ANDA 060572.................  Mycolog II (nystatin  Mylan
                               and triamcinolone     Pharmaceuticals,
                               acetonide) Ointment   Inc., 781 Chestnut
                               USP, 100,000 units/   Ridge Rd., P.O. Box
                               gram (g) and 0.1%.    4310, Morgantown,
                                                     WV 26504.
ANDA 061107.................  Hydrocortisone        Fougera
                               Acetate and           Pharmaceuticals,
                               Neomycin Sulfate      Inc..
                               Ointment,
                               0.5%[hairsp]/
                               [hairsp]0.5% and
                               1.5%[hairsp]/
                               [hairsp]0.5%.
ANDA 061988.................  Polycillin            Bristol-Myers Squibb
                               (ampicillin)          Co., P.O. Box 4000,
                               Capsules, 250         Princeton, NJ
                               milligrams (mg) and   08543.
                               500 mg.
ANDA 072097.................  Cap-Profen            L. Perrigo Co., 515
                               (ibuprofen) Tablets   Eastern Ave.,
                               USP, 200 mg (White).  Allegan, MI 49010.
ANDA 072098.................  Ibuprofen Tablets,     Do.
                               200 mg (Brown).
ANDA 074334.................  Vecuronium Bromide    Watson Laboratories,
                               for Injection, 10     Inc., Subsidiary of
                               mg/vial and 20 mg/    Teva
                               vial.                 Pharmaceuticals
                                                     USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 074874.................  Pentoxifylline        Pliva, Inc.,
                               Extended-Release      Subsidiary of Teva
                               Tablets, 400 mg.      Pharmaceuticals
                                                     USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.

[[Page 40071]]

 
ANDA 074945.................  Atracurium Besylate   Watson Laboratories,
                               Injection, 10 mg/     Inc., Subsidiary of
                               milliliter (mL).      Teva
                                                     Pharmaceuticals
                                                     USA, Inc.
ANDA 077251.................  Finasteride Tablets   Gedeon Richter Plc.,
                               USP, 5 mg.            c/o Gedeon Richter
                                                     USA, Inc., 119
                                                     Cherry Hill Rd.,
                                                     Suite 325,
                                                     Parsippany, NJ
                                                     07054.
ANDA 077983.................  Gemcitabine for       Teva Pharmaceuticals
                               Injection USP,        USA, Inc., 425
                               Equivalent to (EQ)    Privet Rd.,
                               200 mg base/vial      Horsham, PA 19044.
                               and EQ 1 g/vial.
ANDA 080425.................  Texacort              Mission Pharmacal
                               (hydrocortisone)      Co., 10999 IH 10
                               Topical Solution,     West, Suite 1000,
                               1%.                   San Antonio, TX
                                                     78230.
ANDA 083242.................  Amen                  Valeant
                               (medroxyprogesteron   Pharmaceuticals
                               e acetate) Tablets,   North America, LLC,
                               10 mg.                400 Somerset
                                                     Corporate Blvd.,
                                                     Bridgewater, NJ
                                                     08807.
ANDA 085455.................  Dexamethasone         Watson Laboratories,
                               Tablets USP, 0.25     Inc., Subsidiary of
                               mg.                   Teva
                                                     Pharmaceuticals
                                                     USA, Inc..
ANDA 086308.................  Homapin-10            Mission Pharmacal
                               (homatropine          Co.
                               methylbromide)
                               Tablets USP, 10 mg.
ANDA 086309.................  Homapin-5              Do.
                               (homatropine
                               methylbromide)
                               Tablets USP, 5 mg.
ANDA 086310.................  Equipin (homatropine   Do.
                               methylbromide)
                               Chewable Tablets, 3
                               mg.
ANDA 086711.................  Beta-2 (isoetharine   Nephron
                               hydrochloride         Pharmaceuticals,
                               (HCl)) Inhalation     Corp., 4500 12th
                               Solution, 1%.         St. Extension, West
                                                     Columbia, SC 20172.
ANDA 087438.................  Folicet (folic acid)  Mission Pharmacal
                               Tablets USP, 1 mg.    Co.
ANDA 087939.................  Trimethobenzamide     Watson Laboratories,
                               HCl Injection, 100    Inc., Subsidiary of
                               mg/mL.                Teva
                                                     Pharmaceuticals
                                                     USA, Inc.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
September 12, 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 September 12, 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: August 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17226 Filed 8-10-18; 8:45 am]
 BILLING CODE 4164-01-P

40070 Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices Dated: August 7, 2018. ACTION: Notice. Ave., Bldg. 75, Rm. 1671, Silver Spring, Leslie Kux, MD 20993–0002, 240–402–7945, Associate Commissioner for Policy. SUMMARY: The Food and Drug Trang.Tran@fda.hhs.gov. [FR Doc. 2018–17303 Filed 8–10–18; 8:45 am] Administration (FDA or Agency) is withdrawing approval of 20 abbreviated SUPPLEMENTARY INFORMATION: The BILLING CODE 4164–01–C new drug applications (ANDAs) from holders of the applications listed in the multiple applicants. The holders of the table have informed FDA that these drug DEPARTMENT OF HEALTH AND applications notified the Agency in products are no longer marketed and HUMAN SERVICES writing that the drug products were no have requested that FDA withdraw longer marketed and requested that the approval of the applications under the Food and Drug Administration approval of the applications be process described in § 314.150(c) (21 withdrawn. CFR 314.150(c)). The applicants have [Docket No. FDA–2018–N–2876] DATES: Approval is withdrawn as of also, by their requests, waived their Fougera Pharmaceuticals, Inc., et al.; September 12, 2018. opportunity for a hearing. Withdrawal Withdrawal of Approval of 20 of approval of an application or FOR FURTHER INFORMATION CONTACT: Abbreviated New Drug Applications abbreviated application under Trang Tran, Center for Drug Evaluation § 314.150(c) is without prejudice to AGENCY: Food and Drug Administration, and Research, Food and Drug HHS. Administration, 10903 New Hampshire refiling. Application No. Drug Applicant ANDA 060133 ...................... Chloramphenicol Ophthalmic Ointment, 1% ................... Fougera Pharmaceuticals, Inc., 60 Baylis Rd., P.O. Box 2006, Melville, NY 11747. ANDA 060572 ...................... Mycolog II (nystatin and triamcinolone acetonide) Oint- Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., ment USP, 100,000 units/gram (g) and 0.1%. P.O. Box 4310, Morgantown, WV 26504. ANDA 061107 ...................... Hydrocortisone Acetate and Neomycin Sulfate Oint- Fougera Pharmaceuticals, Inc.. ment, 0.5%/0.5% and 1.5%/0.5%. ANDA 061988 ...................... Polycillin (ampicillin) Capsules, 250 milligrams (mg) and Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 500 mg. 08543. sradovich on DSK3GMQ082PROD with NOTICES ANDA 072097 ...................... Cap-Profen (ibuprofen) Tablets USP, 200 mg (White) ... L. Perrigo Co., 515 Eastern Ave., Allegan, MI 49010. ANDA 072098 ...................... Ibuprofen Tablets, 200 mg (Brown) ................................ Do. ANDA 074334 ...................... Vecuronium Bromide for Injection, 10 mg/vial and 20 Watson Laboratories, Inc., Subsidiary of Teva Pharma- mg/vial. ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 074874 ...................... Pentoxifylline Extended-Release Tablets, 400 mg ......... Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. EN13AU18.010</GPH> VerDate Sep<11>2014 21:07 Aug 10, 2018 Jkt 244001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 E:\FR\FM\13AUN1.SGM 13AUN1

Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40071 Application No. Drug Applicant ANDA 074945 ...................... Atracurium Besylate Injection, 10 mg/milliliter (mL) ....... Watson Laboratories, Inc., Subsidiary of Teva Pharma- ceuticals USA, Inc. ANDA 077251 ...................... Finasteride Tablets USP, 5 mg ....................................... Gedeon Richter Plc., c/o Gedeon Richter USA, Inc., 119 Cherry Hill Rd., Suite 325, Parsippany, NJ 07054. ANDA 077983 ...................... Gemcitabine for Injection USP, Equivalent to (EQ) 200 Teva Pharmaceuticals USA, Inc., 425 Privet Rd., mg base/vial and EQ 1 g/vial. Horsham, PA 19044. ANDA 080425 ...................... Texacort (hydrocortisone) Topical Solution, 1% ............. Mission Pharmacal Co., 10999 IH 10 West, Suite 1000, San Antonio, TX 78230. ANDA 083242 ...................... Amen (medroxyprogesterone acetate) Tablets, 10 mg .. Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. ANDA 085455 ...................... Dexamethasone Tablets USP, 0.25 mg ......................... Watson Laboratories, Inc., Subsidiary of Teva Pharma- ceuticals USA, Inc.. ANDA 086308 ...................... Homapin-10 (homatropine methylbromide) Tablets Mission Pharmacal Co. USP, 10 mg. ANDA 086309 ...................... Homapin-5 (homatropine methylbromide) Tablets USP, Do. 5 mg. ANDA 086310 ...................... Equipin (homatropine methylbromide) Chewable Tab- Do. lets, 3 mg. ANDA 086711 ...................... Beta-2 (isoetharine hydrochloride (HCl)) Inhalation So- Nephron Pharmaceuticals, Corp., 4500 12th St. Exten- lution, 1%. sion, West Columbia, SC 20172. ANDA 087438 ...................... Folicet (folic acid) Tablets USP, 1 mg ............................ Mission Pharmacal Co. ANDA 087939 ...................... Trimethobenzamide HCl Injection, 100 mg/mL .............. Watson Laboratories, Inc., Subsidiary of Teva Pharma- ceuticals USA, Inc. Therefore, approval of the other reasonable accommodations in Dated: August 8, 2018. applications listed in the table, and all order to do so, should notify the Contact David D. Clary, amendments and supplements thereto, Person listed below in advance of the Program Analyst, Office of Federal Advisory is hereby withdrawn as of September meeting. Committee Policy. 12, 2018. Introduction or delivery for Name of Committee: Advisory Committee [FR Doc. 2018–17345 Filed 8–10–18; 8:45 am] introduction into interstate commerce of to the Director, National Institutes of Health. BILLING CODE 4140–01–P products without approved new drug Date: August 24, 2018. applications violates section 301(a) and Time: 9:15 a.m. to 9:45 a.m. (d) of the Federal Food, Drug, and Agenda: Updates on ACD Working Groups. DEPARTMENT OF HEALTH AND Cosmetic Act (21 U.S.C. 331(a) and (d)). Place: National Institutes of Health, HUMAN SERVICES Drug products that are listed in the table Building 1, One Center Drive, Bethesda, MD that are in inventory on September 12, 20892 (Telephone Conference Call), 800– National Institutes of Health 369–1915, Access Code: 6496247. 2018 may continue to be dispensed Contact Person: Gretchen Wood, Staff until the inventories have been depleted Proposed Collection; 60-Day Comment Assistant, National Institutes of Health, Request; National Cancer Institute or the drug products have reached their Office of the Director, One Center Drive, expiration dates or otherwise become Building 1, Room 126, Bethesda, MD 20892, (NCI) Future Fellows Resume Databank violative, whichever occurs first. 301–496–4272, Woodgs@od.nih.gov. AGENCY: National Institutes of Health, Dated: August 7, 2018. This notice is being published less than 15 HHS. Leslie Kux, days prior to the meeting due to scheduling ACTION: Notice. difficulties. Associate Commissioner for Policy. Any interested person may file written SUMMARY: In compliance with the [FR Doc. 2018–17226 Filed 8–10–18; 8:45 am] comments with the committee by forwarding requirement of the Paperwork BILLING CODE 4164–01–P the statement to the Contact Person listed on this notice. The statement should include the Reduction Act of 1995 to provide name, address, telephone number and when opportunity for public comment on DEPARTMENT OF HEALTH AND applicable, the business or professional proposed data collection projects, the HUMAN SERVICES affiliation of the interested person. National Institutes of Health, National Information is also available on the Cancer Institute (NCI) will publish National Institutes of Health Institute’s/Center’s home page: http:// periodic summaries of propose projects acd.od.nih.gov, where an agenda and any to be submitted to the Office of Office of the Director, National additional information for the meeting will Management and Budget (OMB) for be posted when available. Institutes of Health; Notice of Meeting review and approval. (Catalogue of Federal Domestic Assistance DATES: Comments regarding this Pursuant to section 10(a) of the Program Nos. 93.14, Intramural Research Federal Advisory Committee Act, as Training Award; 93.22, Clinical Research information collection are best assured amended, notice is hereby given of a Loan Repayment Program for Individuals of having their full effect if received from Disadvantaged Backgrounds; 93.232, within 60 days of the date of this sradovich on DSK3GMQ082PROD with NOTICES meeting of the Advisory Committee to the Director, National Institutes of Loan Repayment Program for Research publication. Generally; 93.39, Academic Research Health. FOR FURTHER INFORMATION CONTACT: To Enhancement Award; 93.936, NIH Acquired The meeting will be held as a Immunodeficiency Syndrome Research Loan obtain a copy of the data collection teleconference call only and is open to Repayment Program; 93.187, Undergraduate plans and instruments, submit the public to dial-in for participation. Scholarship Program for Individuals from comments in writing, or request more Individuals who plan to dial-in to the Disadvantaged Backgrounds, National information on the proposed project, meeting and need special assistance or Institutes of Health, HHS) contact: Angela Jones, Program VerDate Sep<11>2014 20:42 Aug 10, 2018 Jkt 244001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 E:\FR\FM\13AUN1.SGM 13AUN1


Document Created: 2018-08-11 00:27:40
Document Modified: 2018-08-11 00:27:40
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesApproval is withdrawn as of September 12, 2018.
ContactTrang 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 Citation83 FR 40070 
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