83_FR_48822 83 FR 48635 - Aurolife Pharma, LLC, et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications

83 FR 48635 - Aurolife Pharma, LLC, et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 187 (September 26, 2018)

Page Range48635-48636
FR Document2018-20947

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in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Federal Register, Volume 83 Issue 187 (Wednesday, September 26, 2018) 
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48635-48636]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20947]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3463]


Aurolife Pharma, LLC, et al.; Withdrawal of Approval of Seven 
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 seven 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of October 26, 2018.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 072112.................  Clorazepate           Aurolife Pharma,
                               Dipotassium           LLC, 279 Princeton
                               Capsules, 3.75        Hightstown Rd.,
                               milligrams (mg),      East Windsor, NJ
                               7.5 mg, and 15 mg.    08520.
ANDA 074863.................  Clemastine Fumarate   Workhardt Bio AG, c/
                               Syrup, Equivalent     o Morton Grove
                               to (EQ) 0.5 mg base/  Pharmaceuticals,
                               5 milliliters (mL).   Inc., 6451 Main
                                                     St., Morton Grove,
                                                     IL 60053.
ANDA 080925.................  Isocaine 3%           Septodont, Inc., c/o
                               (mepivacaine          Arent Fox, LLP,
                               hydrochloride         1717 K St. NW,
                               (HCl)) Injection      Washington, DC
                               USP, 3%.              20006.
ANDA 084048.................  Octocaine (lidocaine   Do.
                               HCl and
                               epinephrine)
                               Injection USP, 2%;
                               0.01 mg/mL and 2%;
                               0.02 mg/mL.
ANDA 084697.................  Isocaine 2%            Do.
                               (mepivacaine HCl
                               and levonordefrin)
                               Injection USP, 2%;
                               0.05 mg/mL.
ANDA 086033.................  Isosorbide Dinitrate  Watson Laboratories,
                               Sublingual Tablets    Inc., Subsidiary of
                               USP, 2.5 mg.          Teva
                                                     Pharmaceuticals
                                                     USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 087504.................  Chloroquine           Teva Pharmaceuticals
                               Phosphate Tablets     USA, Inc., 425
                               USP, EQ 150 mg base.  Privet Rd.,
                                                     Horsham, PA 19044.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
October 26, 2018. Introduction or delivery for introduction into 
interstate commerce of

[[Page 48636]]

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 26, 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 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20947 Filed 9-25-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices 48635 information line to learn about possible or before October 23, 2018. Time DEPARTMENT OF HEALTH AND modifications before coming to the allotted for each presentation may be HUMAN SERVICES meeting. limited. If the number of registrants requesting to speak is greater than can Food and Drug Administration SUPPLEMENTARY INFORMATION: Agenda: On November 7, 2018, the be reasonably accommodated during the [Docket No. FDA–2018–N–3463] Center for Biologics Evaluation and scheduled open public hearing session, Research’s APAC will meet in open FDA may conduct a lottery to determine Aurolife Pharma, LLC, et al.; session to discuss the use of challenge the speakers for the scheduled open Withdrawal of Approval of Seven studies in the clinical development of public hearing session. The contact Abbreviated New Drug Applications allergenic products for the diagnosis person will notify interested persons AGENCY: Food and Drug Administration, and treatment of allergy due to regarding their request to speak by HHS. aeroallergens. FDA intends to make October 24, 2018. ACTION: Notice. background material available to the Persons attending FDA’s advisory public no later than 2 business days committee meetings are advised that the SUMMARY: The Food and Drug before the meeting. If FDA is unable to Agency is not responsible for providing Administration (FDA or Agency) is post the background material on its access to electrical outlets. withdrawing approval of seven website prior to the meeting, the abbreviated new drug applications background material will be made FDA welcomes the attendance of the public at its advisory committee (ANDAs) from multiple applicants. The publicly available at the location of the applicants notified the Agency in advisory committee meeting, and the meetings and will make every effort to writing that the drug products were no background material will be posted on accommodate persons with disabilities. longer marketed and requested that the FDA’s website after the meeting. If you require accommodations due to a approval of the applications be Background material is available at disability, please contact Serina Hunter- withdrawn. https://www.fda.gov/Advisory Thomas at least 7 days in advance of the Committees/Calendar/default.htm. meeting. DATES: Approval is withdrawn as of Scroll down to the appropriate advisory October 26, 2018. FDA is committed to the orderly committee meeting link. FOR FURTHER INFORMATION CONTACT: conduct of its advisory committee Procedure: On November 7, 2018, Trang Tran, Center for Drug Evaluation meetings. Please visit our website at: from 9 a.m. to 4 p.m., the meeting is and Research, Food and Drug https://www.fda.gov/Advisory open to the public. Interested persons Administration, 10903 New Hampshire Committees/AboutAdvisoryCommittees/ may present data, information, or views, Ave., Bldg. 75, Rm. 1671, Silver Spring, ucm111462.htm for procedures on MD 20993–0002, 240–402–7945, orally or in writing, on issues pending public conduct during advisory before the committee. Written Trang.Tran@fda.hhs.gov. committee meetings. submissions may be made to the contact SUPPLEMENTARY INFORMATION: The person on or before October 31, 2018. Notice of this meeting is given under applicants listed in the table have Oral presentations from the public will the Federal Advisory Committee Act (5 informed FDA that these drug products be scheduled between approximately U.S.C. app. 2). are no longer marketed and have 12:30 p.m. to 1:30 p.m. Those Dated: September 20, 2018. requested that FDA withdraw approval individuals interested in making formal Leslie Kux, of the applications under the process oral presentations should notify the described in § 314.150(c) (21 CFR Associate Commissioner for Policy. contact person and submit a brief 314.150(c)). The applicants have also, statement of the general nature of the [FR Doc. 2018–20905 Filed 9–25–18; 8:45 am] by their requests, waived their evidence or arguments they wish to BILLING CODE 4164–01–P opportunity for a hearing. Withdrawal present, the names and addresses of of approval of an application or proposed participants, and an abbreviated application under indication of the approximate time § 314.150(c) is without prejudice to requested to make their presentation on refiling. Application No. Drug Applicant ANDA 072112 ...................... Clorazepate Dipotassium Capsules, 3.75 milligrams Aurolife Pharma, LLC, 279 Princeton Hightstown Rd., (mg), 7.5 mg, and 15 mg. East Windsor, NJ 08520. ANDA 074863 ...................... Clemastine Fumarate Syrup, Equivalent to (EQ) 0.5 mg Workhardt Bio AG, c/o Morton Grove Pharmaceuticals, base/5 milliliters (mL). Inc., 6451 Main St., Morton Grove, IL 60053. ANDA 080925 ...................... Isocaine 3% (mepivacaine hydrochloride (HCl)) Injec- Septodont, Inc., c/o Arent Fox, LLP, 1717 K St. NW, tion USP, 3%. Washington, DC 20006. ANDA 084048 ...................... Octocaine (lidocaine HCl and epinephrine) Injection Do. USP, 2%; 0.01 mg/mL and 2%; 0.02 mg/mL. ANDA 084697 ...................... Isocaine 2% (mepivacaine HCl and levonordefrin) Injec- Do. tion USP, 2%; 0.05 mg/mL. ANDA 086033 ...................... Isosorbide Dinitrate Sublingual Tablets USP, 2.5 mg .... Watson Laboratories, Inc., Subsidiary of Teva Pharma- ceuticals USA, Inc., 425 Privet Rd., Horsham, PA daltland on DSKBBV9HB2PROD with NOTICES 19044. ANDA 087504 ...................... Chloroquine Phosphate Tablets USP, EQ 150 mg base Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. Therefore, approval of the amendments and supplements thereto, 2018. Introduction or delivery for applications listed in the table, and all is hereby withdrawn as of October 26, introduction into interstate commerce of VerDate Sep<11>2014 19:21 Sep 25, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1

48636 Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices products without approved new drug certain types of abbreviated applications II. Revenue Amount for FY 2019 applications violates section 301(a) and for generic new animal drugs; (2) annual A. Statutory Fee Revenue Amounts (d) of the Federal Food, Drug, and fees for certain generic new animal drug Cosmetic Act (21 U.S.C. 331(a) and (d)). products; and (3) annual fees for certain AGDUFA III, Title II of Public Law Drug products that are listed in the table sponsors of abbreviated applications for 115–234, specifies that the aggregate that are in inventory on October 26, generic new animal drugs and/or revenue amount for FY 2019 for all 2018 may continue to be dispensed investigational submissions for generic generic new animal drug user fee until the inventories have been depleted categories is $18,336,000 (rounded to new animal drugs (21 U.S.C. 379j– or the drug products have reached their the nearest thousand dollars) (21 U.S.C. 21(a)). When certain conditions are met, 379j–21(b)(1)). expiration dates or otherwise become FDA will waive or reduce fees for violative, whichever occurs first. generic new animal drugs intended B. Inflation Adjustment to Fee Revenue Dated: September 20, 2018. solely to provide for a minor use or Amount Leslie Kux, minor species indication (21 U.S.C. AGDUFA III specifies that the annual Associate Commissioner for Policy. 379j–21(d)). fee revenue amount is to be adjusted for [FR Doc. 2018–20947 Filed 9–25–18; 8:45 am] For FY 2019 through FY 2023, the inflation increases for FY 2020 and BILLING CODE 4164–01–P FD&C Act establishes a yearly base subsequent fiscal years, using two revenue amount and percentages for separate adjustments—one for personnel compensation and benefits (PC&B) and each of these fee categories (21 U.S.C. DEPARTMENT OF HEALTH AND one for non-PC&B costs (see 21 U.S.C. 379j–21(b)). Base revenue amounts HUMAN SERVICES 379j–21(c)(2)). The component of the established for fiscal years after FY 2019 inflation adjustment for payroll costs Food and Drug Administration are subject to adjustment for inflation shall be one plus the average annual and workload. Workload increases will percent change in the cost of all PC&B [Docket No. FDA–2018–N–0007] be adjusted for excess collections after paid per full-time equivalent position at Animal Generic Drug User Fee Rates FY 2020 (21 U.S.C. 379j–21(c)). The FDA for the first 3 of the 4 preceding and Payment Procedures for Fiscal target revenue amounts for each fee fiscal years, multiplied by the average Year 2019 category for FY 2019, are as follows: For proportion of PC&B costs to total FDA application fees, the target revenue costs for the first 3 of the 4 preceding AGENCY: Food and Drug Administration, amount is $4,584,000; for product fees, fiscal years. The statute specifies that HHS. the target revenue amount is $6,876,000; the portion of the inflation adjustment ACTION: Notice. and for sponsor fees, the target revenue for non-payroll costs is the average amount is $6,876,000. annual percent change that occurred in SUMMARY: The Food and Drug For FY 2019, the generic new animal the Consumer Price Index for urban Administration (FDA or Agency) is drug user fee rates are: $424,444 for consumers (Washington-Baltimore, DC– announcing the fee rates and payment each abbreviated application for a MD–VA–WV; not seasonally adjusted; procedures for fiscal year (FY) 2019 generic new animal drug other than all items less food and energy; annual generic new animal drug user fees. The index) for the first 3 of the preceding 4 Federal Food, Drug, and Cosmetic Act those subject to the criteria in section years of available data multiplied by the (FD&C Act), as amended by the Animal 512(d)(4) of the FD&C Act (21 U.S.C. proportion of all costs other than PC&B Generic Drug User Fee Amendments of 360b(d)(4)); $212,222 for each costs to total FDA costs. Because the 2018 (AGDUFA III), authorizes FDA to abbreviated application for a generic adjustment for inflation does not take collect user fees for certain abbreviated new animal drug subject to the criteria effect until FY 2020, FDA will not applications for generic new animal in section 512(d)(4); $15,486 for each adjust the FY 2019 fee revenue amount drugs, for certain generic new animal generic new animal drug product; for inflation. drug products, and for certain sponsors $150,098 for each generic new animal of such abbreviated applications for drug sponsor paying 100 percent of the C. Workload Adjustment to Inflation generic new animal drugs and/or sponsor fee; $112,574 for each generic Adjusted Fee Revenue Amount investigational submissions for generic new animal drug sponsor paying 75 The fee revenue amounts established new animal drugs. This notice percent of the sponsor fee; and $75,049 in AGDUFA III for FY 2020 and establishes the fee rates for FY 2019. subsequent fiscal years are also subject for each generic new animal drug FOR FURTHER INFORMATION CONTACT: Visit sponsor paying 50 percent of the to adjustment to account for changes in FDA’s website at https://www.fda.gov/ sponsor fee. FDA will issue invoices for FDA’s review workload. A workload ForIndustry/UserFees/AnimalGeneric FY 2019 product and sponsor fees by adjustment will be applied to the DrugUserFeeActAGDUFA/default.htm, inflation adjusted fee revenue amount December 31, 2018. These fees will be or contact Lisa Kable, Center for (21 U.S.C. 379j–21(c)(3)). due by January 31, 2019. The Veterinary Medicine (HFV–10), Food AGDUFA III specifies that FDA shall application fee rates are effective for all and Drug Administration, 7500 Standish calculate the weighted average of the Pl., Rockville, MD 20855, 240–402– abbreviated applications for a generic change in the total number of each of 6888, Lisa.Kable@fda.hhs.gov. For new animal drug submitted on or after the four types of applications and general questions, you may also email October 1, 2018, and will remain in submissions specified in the workload the Center for Veterinary Medicine effect through September 30, 2019. adjustment provision (abbreviated daltland on DSKBBV9HB2PROD with NOTICES (CVM) at cvmagdufa@fda.hhs.gov. Applications will not be accepted for applications for generic new animal SUPPLEMENTARY INFORMATION: review until FDA has received full drugs, manufacturing supplemental payment of related application fees and abbreviated applications for generic new I. Background any other fees owed under the Animal animal drugs, investigational generic Section 741 of the FD&C Act (21 Generic Drug User Fee program new animal drug study submissions, U.S.C. 379j–21) establishes three (AGDUFA program). and investigational generic new animal different types of user fees: (1) Fees for drug protocol submissions). Because the VerDate Sep<11>2014 19:21 Sep 25, 2018 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1


Document Created: 2018-09-26 00:46:53
Document Modified: 2018-09-26 00:46:53
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 October 26, 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 48635 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR