83 FR 19787 - Ferndale Laboratories, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 87 (May 4, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 87 (May 4, 2018)
| Page Range | 19787-19788 | |
| FR Document | 2018-09534 |
[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)] [Notices] [Pages 19787-19788] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-09534] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1564] Ferndale Laboratories, Inc., et al.; Withdrawal of Approval of Nine 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 nine 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of June 4, 2018.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 [[Page 19788]] 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 040259..................... Hydrocortisone Ferndale Acetate Cream Laboratories, USP, 2.5%. Inc., 780 West Eight Mile Rd., Ferndale, MI 48220. ANDA 040457..................... Pyridostigmine Impax Bromide Tablets Laboratories, USP, 60 Inc., 30831 milligrams (mg). Huntwood Ave., Hayward, CA 94544. ANDA 061806..................... Cloxapen GlaxoSmithKline, (cloxacillin LLC, 5 Crescent sodium) Capsules, Dr., Equivalent to Philadelphia, PA (EQ) 250 mg base 19112. and EQ 500 mg base. ANDA 065453..................... Vancomycin Fresenius Kabi Hydrochloride USA, LLC, Three (HCl) Capsules Corporate Dr., USP, EQ 125 mg Lake Zurich, IL base and EQ 250 60047. mg base. ANDA 075836..................... Calcitriol Do. Injection, 1 microgram (mcg)/ milliliter (mL) and 2 mcg/mL. ANDA 075916..................... Rimantadine HCl Impax Tablets USP, 100 Laboratories, mg. Inc. ANDA 076731..................... Glyburide and Do. Metformin HCl Tablets USP, 1.25 mg/250 mg, 2.5 mg/ 500 mg, and 5 mg/ 500 mg. ANDA 076889..................... Fluconazole in Mylan Sodium Chloride Laboratories, 0.9% Injection, Ltd., c/o Mylan 200 mg/100 mL and Pharmaceuticals, 400 mg/200 mL. Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504. ANDA 088572..................... Pediatric LTA Kit Abbott (lidocaine HCl) Laboratories, One Solution, 2%. Abbott Park Rd., Abbott Park, IL 60064. ------------------------------------------------------------------------ Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of June 4, 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 June 4, 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: May 1, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-09534 Filed 5-3-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices 19787
Dated: April 23, 2018. incorrect docket number. This SUMMARY: The Food and Drug
Seema Verma, document corrects that error. Administration (FDA or Agency) is
Administrator, Centers for Medicare & FOR FURTHER INFORMATION CONTACT: Lisa withdrawing approval of three
Medicaid Services. Granger, Office of Policy and Planning, abbreviated new drug applications
[FR Doc. 2018–09532 Filed 5–3–18; 8:45 am] Food and Drug Administration, 10903 (ANDAs) held by Sun Pharmaceutical
BILLING CODE 4120–01–P New Hampshire Ave., Bldg. 32, Rm. Industries, Ltd., c/o Sun Pharmaceutical
3330, Silver Spring, MD 20993–0002, Industries, Inc. (Sun Pharmaceutical).
301–796–9115. These drug products are no longer
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: In the marketed, and Sun Pharmaceutical has
HUMAN SERVICES Federal Register of Tuesday, April 9, requested that the approval of the
2018 (83 FR 15152), in FR Doc. 2018– applications be withdrawn.
Food and Drug Administration 07147, on page 15152, the following DATES: Approval is withdrawn as of
[Docket Nos. FDA–2011–N–0075; FDA– correction is made: June 4, 2018.
2011–N–0015; FDA–2011–N–0076; FDA– 1. On page 15152, in the second
2017–N–0932; FDA–2016–N–4487; FDA– column, in the first line of the list of FOR FURTHER INFORMATION CONTACT:
2014–N–0345; FDA–2013–N–0523; FDA– docket numbers, ‘‘FDA–2014–N–0075’’ Trang Tran, Center for Drug Evaluation
2017–N–2428; FDA–2008–N–0312; and is corrected to read ‘‘FDA–2011–N– and Research, Food and Drug
FDA–2014–N–1072]
0075.’’ Administration, 10903 New Hampshire
Agency Information Collection Dated: April 30, 2018. Ave., Bldg. 75, Rm. 1671, Silver Spring,
Activities; Announcement of Office of Leslie Kux, MD 20993–0002, 240–402–7945,
Management and Budget Approvals; Associate Commissioner for Policy. Trang.Tran@fda.hhs.gov.
Correction [FR Doc. 2018–09437 Filed 5–3–18; 8:45 am] SUPPLEMENTARY INFORMATION: Sun
AGENCY: Food and Drug Administration, BILLING CODE 4164–01–P Pharmaceutical has informed FDA that
HHS. these drug products are no longer
ACTION: Notice; correction. marketed and requested that FDA
DEPARTMENT OF HEALTH AND withdraw approval of the applications.
SUMMARY: The Food and Drug HUMAN SERVICES Sun Pharmaceutical has also waived its
Administration is correcting a notice opportunity for a hearing and requested
entitled ‘‘Agency Information Collection Food and Drug Administration withdrawal of approval under a Consent
Activities; Announcement of Office of [Docket No. FDA–2018–N–1534] Decree of Permanent Injunction (Decree)
Management and Budget Approvals’’ entered in United States v. Ranbaxy
that appeared in the Federal Register of Sun Pharmaceutical Industries, Ltd.; Laboratories, Ltd. et al., JFM 12–250 (D.
April 9, 2018. The document announced Withdrawal of Approval of Three Md.) on January 26, 2012. The Decree
a list of information collections that Abbreviated New Drug Applications specifies that Sun Pharmaceutical must
have been approved by the Office of AGENCY: Food and Drug Administration, never submit another application to
Management and Budget (OMB) under HHS. FDA for these withdrawn drugs and
the Paperwork Reduction Act of 1995. must never transfer these ANDAs to a
ACTION: Notice.
The document was published with an third party.
Application No. Drug Applicant
ANDA 065174 ......... Clarithromycin Tablets USP, 250 milligrams (mg) and 500 Sun Pharmaceutical Industries, Ltd., c/o Sun Pharma-
mg. ceutical Industries, Inc., 2 Independence Way, Princeton,
NJ 08540.
ANDA 065382 ......... Clarithromycin for Oral Suspension USP, 125 mg/5 milli- Do.
liters (mL) and 250 mg/5 mL.
ANDA 075747 ......... Ciprofloxacin Tablets USP, Equivalent to (EQ) 250 mg Do.
base, EQ 500 mg base, and EQ 750 mg base.
Therefore, approval of the DEPARTMENT OF HEALTH AND holders of the applications notified the
applications listed in the above table, HUMAN SERVICES Agency in writing that the drug
and all amendments and supplements products were no longer marketed and
thereto, is hereby withdrawn as of June Food and Drug Administration requested that the approval of the
4, 2018. Introduction or delivery for [Docket No. FDA–2018–N–1564] applications be withdrawn.
introduction into interstate commerce of DATES: Approval is withdrawn as of
products without approved new drug Ferndale Laboratories, Inc., et al.; June 4, 2018.
applications violates section 301(a) and Withdrawal of Approval of Nine FOR FURTHER INFORMATION CONTACT:
(d) of the Federal Food, Drug, and Abbreviated New Drug Applications Trang Tran, Center for Drug Evaluation
Cosmetic Act (21 U.S.C. 331(a) and (d)). AGENCY: Food and Drug Administration, and Research, Food and Drug
HHS. Administration, 10903 New Hampshire
Dated: May 1, 2018.
amozie on DSK3GDR082PROD with NOTICES
Ave., Bldg. 75, Rm. 1671, Silver Spring,
Leslie Kux, ACTION: Notice.
MD 20993–0002, 240–402–7945,
Associate Commissioner for Policy. SUMMARY: The Food and Drug Trang.Tran@fda.hhs.gov.
[FR Doc. 2018–09533 Filed 5–3–18; 8:45 am] Administration (FDA or Agency) is SUPPLEMENTARY INFORMATION: The
BILLING CODE 4164–01–P withdrawing approval of nine holders of the applications listed in the
abbreviated new drug applications table have informed FDA that these drug
(ANDAs) from multiple applicants. The products are no longer marketed and
VerDate Sep<11>2014 18:16 May 03, 2018 Jkt 244001 PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM 04MYN1](https://thefederalregister.org/doc/83_FR_19874/page/1.svg)
![19788 Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices
have requested that FDA withdraw also, by their requests, waived their § 314.150(c) is without prejudice to
approval of the applications under the opportunity for a hearing. Withdrawal refiling.
process described in § 314.150(c) (21 of approval of an application or
CFR 314.150(c)). The applicants have abbreviated application under
Application No. Drug Applicant
ANDA 040259 ......... Hydrocortisone Acetate Cream USP, 2.5% .......................... Ferndale Laboratories, Inc., 780 West Eight Mile Rd., Fern-
dale, MI 48220.
ANDA 040457 ......... Pyridostigmine Bromide Tablets USP, 60 milligrams (mg) ... Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward,
CA 94544.
ANDA 061806 ......... Cloxapen (cloxacillin sodium) Capsules, Equivalent to (EQ) GlaxoSmithKline, LLC, 5 Crescent Dr., Philadelphia, PA
250 mg base and EQ 500 mg base. 19112.
ANDA 065453 ......... Vancomycin Hydrochloride (HCl) Capsules USP, EQ 125 Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zu-
mg base and EQ 250 mg base. rich, IL 60047.
ANDA 075836 ......... Calcitriol Injection, 1 microgram (mcg)/milliliter (mL) and 2 Do.
mcg/mL.
ANDA 075916 ......... Rimantadine HCl Tablets USP, 100 mg ................................ Impax Laboratories, Inc.
ANDA 076731 ......... Glyburide and Metformin HCl Tablets USP, 1.25 mg/250 Do.
mg, 2.5 mg/500 mg, and 5 mg/500 mg.
ANDA 076889 ......... Fluconazole in Sodium Chloride 0.9% Injection, 200 mg/ Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc.,
100 mL and 400 mg/200 mL. 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown,
WV 26504.
ANDA 088572 ......... Pediatric LTA Kit (lidocaine HCl) Solution, 2% ..................... Abbott Laboratories, One Abbott Park Rd., Abbott Park, IL
60064.
Therefore, approval of the Application Due Date has been Register on April 17, 2018, for the
applications listed in the table, and all modified. Planning Cooperative Agreement,
amendments and supplements thereto, FOR FURTHER INFORMATION CONTACT: Paul Funding Announcement Number: HHS–
is hereby withdrawn as of June 4, 2018. Gettys, Grant Systems Coordinator, 5600 2018–IHS–TSGP–0001. The Application
Introduction or delivery for introduction Fishers Lane, Mail Stop: 09E70, Due Date has been modified.
into interstate commerce of products Rockville, MD 20857, Phone: (301) 443– FOR FURTHER INFORMATION CONTACT: Paul
without approved new drug 2114; or the Division of Grants Gettys, Grant Systems Coordinator, 5600
applications violates section 301(a) and Management main line (301) 443–5204, Fishers Lane, Mail Stop: 09E70,
(d) of the Federal Food, Drug, and or Fax: (301)–594–0899. Rockville, MD 20857, Phone: (301) 443–
Cosmetic Act (21 U.S.C. 331(a) and (d)). 2114; or the Division of Grants
Drug products that are listed in the table Correction Management main line (301) 443–5204,
that are in inventory on June 4, 2018 In the FR notice of April 17, 2018, (FR or Fax: (301) 594–0899.
may continue to be dispensed until the 2018–07941), the correction is:
inventories have been depleted or the Key Dates: Correction
drug products have reached their Under the heading Key Dates, the In the FR notice of April 17, 2018, (FR
expiration dates or otherwise become Application Due Date should read as: 83 FR 16885), the correction is:
violative, whichever occurs first. • Application Due Date: June 18, Key Dates:
2018 Under the heading Key Dates, the
Dated: May 1, 2018.
The other dates in the Key Dates Application Due Date should read as:
Leslie Kux, section remain as originally published.
Associate Commissioner for Policy.
• Application Due Date: June 18, 2018
Dated: April 27, 2018. The other dates in the Key Dates
[FR Doc. 2018–09534 Filed 5–3–18; 8:45 am]
Michael D. Weahkee, section remain as originally published.
BILLING CODE 4164–01–P
RADM, Assistant Surgeon General, U.S.
Dated: April 27, 2018.
Public Health Service, Acting Director, Indian
Health Service. Michael D. Weahkee,
DEPARTMENT OF HEALTH AND [FR Doc. 2018–09506 Filed 5–3–18; 8:45 am] Assistant Surgeon General, U.S. Public Health
HUMAN SERVICES Service, Acting Director, Indian Health
BILLING CODE 4160–16–P
Service.
Indian Health Service [FR Doc. 2018–09507 Filed 5–3–18; 8:45 am]
Office of Tribal Self-Governance; DEPARTMENT OF HEALTH AND BILLING CODE 4165–16–P
Negotiation Cooperative Agreement; HUMAN SERVICES
Correction of Due Date Indian Health Service DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY: Indian Health Service, HHS. Planning Cooperative Agreement;
ACTION: Notice; Correction of due date. Correction of Due Date National Institutes of Health
amozie on DSK3GDR082PROD with NOTICES
AGENCY: Office of Tribal Self- National Institute on Aging; Notice of
SUMMARY: The Indian Health Service Governance, Indian Health Service, Closed Meeting
published a notice in the Federal HHS.
Register (FR) on April 17, 2018, for the ACTION: Notice; correction of due date. Pursuant to section 10(d) of the
Negotiation Cooperative Agreement, Federal Advisory Committee Act, as
Funding Announcement Number: HHS– SUMMARY: The Indian Health Service amended, notice is hereby given of the
2018–IHS–TSGN–0001. The published a notice in the Federal following meeting.
VerDate Sep<11>2014 18:16 May 03, 2018 Jkt 244001 PO 00000 Frm 00109 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM 04MYN1](https://thefederalregister.org/doc/83_FR_19874/page/2.svg)
Document Created: 2018-11-02 09:53:04
Document Modified: 2018-11-02 09:53:04
| 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 June 4, 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 19787 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR