Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications
Federal Register, Volume 83 Issue 37 (Friday, February 23, 2018)
Federal Register Volume 83, Number 37 (Friday, February 23, 2018)
Notices
Pages 8089-8090
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2018-03700
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2018-N-0478
Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 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 24 abbreviated
Page 8090
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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES: Approval is withdrawn as of March 26, 2018.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 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 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 040398............ MiCort-HC Sebela Ireland, Ltd.,
(hydrocortisone c/o Sebela
acetate) Cream USP, 2%. Pharmaceuticals,
Inc., 645 Hembree
Parkway, Suite 1,
Roswell, GA 30076.
ANDA 071893............ Acetohexamide Tablets, Watson Laboratories,
250 milligrams (mg). Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 071894............ Acetohexamide Tablets, Do.
500 mg.
ANDA 073143............ Cyclobenzaprine Do.
Hydrochloride (HCl)
Tablets USP, 10 mg.
ANDA 074576............ Captopril Tablets USP, Do.
12.5 mg, 25 mg, 50 mg,
and 100 mg.
ANDA 076607............ Quinapril Tablets USP, Sun Pharmaceutical
Equivalent to (EQ) 5 Industries, Ltd., c/o
mg base, EQ 10 mg Sun Pharmaceutical
base, EQ 20 mg base, Industries, Inc., 2
and EQ 40 mg base. Independence Way,
Princeton, NJ 08540.
ANDA 076786............ Donepezil HCl Tablets Do.
USP, 5 mg and 10 mg.
ANDA 077483............ Benazepril HCl and Do.
Hydrochlorothiazide
Tablets, 5 mg/6.25 mg,
10 mg/12.5 mg, 20 mg/
12.5 mg, and 20 mg/25
mg.
ANDA 078502............ Eliphos (calcium Cypress
acetate) Tablets USP, Pharmaceutical, Inc.,
667 mg. 10 North Park Pl.,
Suite 201,
Morristown, NJ 07960.
ANDA 081019............ Chlorzoxazone Tablets Watson Laboratories,
USP, 500 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 083821............ Brompheniramine Maleate Do.
Injection, 10 mg/
milliliter (mL).
ANDA 084408............ Bethanechol Chloride Do.
Tablets USP, 10 mg.
ANDA 084441............ Bethanechol Chloride Do.
Tablets USP, 25 mg.
ANDA 085283............ Theolair (theophylline) 3M Drug Delivery
Tablets, 125 mg and Systems, 3M Center,
250 mg. Bldg. 275-3E-02, 2510
Conway Ave., St.
Paul, MN 55144.
ANDA 085738............ Betamethasone Sodium Watson Laboratories,
Phosphate Injection, Inc., Subsidiary of
EQ 3 mg base/mL. Teva Pharmaceuticals
USA, Inc.
ANDA 087444............ Bethanechol Chloride Watson Laboratories,
Tablets USP, 50 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 087792............ Fluorouracil Injection Spectrum
USP, 50 mg/mL. Pharmaceuticals,
Inc., 157 Technology
Dr., Irvine, CA
92618.
ANDA 087978............ Diphenhydramine HCl LNK International,
Capsules, 50 mg. Inc., 145 Ricefield
Ln., Hauppauge, NY
11788.
ANDA 090417............ Carbinoxamine Maleate Cypress
Tablets USP, 4 mg. Pharmaceutical, Inc.
ANDA 090418............ Carbinoxamine Maleate Do.
Oral Solution, 4 mg/5
mL.
ANDA 090468............ Zyfrel (acetaminophen Do.
and hydrocodone
bitartrate) Oral
Solution, 325 mg/7.5
mg per 15 mL.
ANDA 091034............ Dorzolamide HCl Zambon S.p.A., c/o
Ophthalmic Solution Camargo
USP, EQ 2% base. Pharmaceutical
Services, LLC, 9825
Kenwood Rd., Suite
203, Cincinnati, OH
45242.
ANDA 200794............ Pantoprazole Sodium Sun Pharmaceutical
Delayed-Release Industries, Ltd., c/o
Tablets USP, EQ 20 mg Sun Pharmaceutical
base and EQ 40 mg base. Industries, Inc.
ANDA 206438............ Hydrocodone Bitartrate Tris Pharma, Inc.,
and Chlorpheniramine 2033 Route 130, Suite
Maleate Oral Solution, D, Monmouth Junction,
5 mg/4 mg per 5 mL. NJ 08852.
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Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of March 26, 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 March 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: February 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
FR Doc. 2018-03700 Filed 2-22-18; 8:45 am
BILLING CODE 4164-01-P
