Ferndale Laboratories, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications

Federal Register, Volume 83 Issue 87 (Friday, May 4, 2018)

Federal Register Volume 83, Number 87 (Friday, May 4, 2018)

Notices

Pages 19787-19788

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2018-09534

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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.

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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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of June 4, 2018.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.

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Application No. Drug Applicant

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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.

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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

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