Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. et al.; Withdrawal of Approval of 111 Abbreviated New Drug Applications

 
CONTENT

Federal Register, Volume 83 Issue 1 (Tuesday, January 2, 2018)

Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)

Notices

Pages 128-131

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

FR Doc No: 2017-28254

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. FDA-2017-N-6852

Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. et al.; Withdrawal of Approval of 111 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 111 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of February 1, 2018.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,

Page 129

MD 20993-0002, 240-402-7945, email protected.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in table 1 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.

Table 1

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Application No. Drug Applicant

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ANDA 040008......... Heparin Sodium Injection Watson Laboratories,

USP, 1000 units/ Inc., Subsidiary of

milliliter (mL). Teva Pharmaceuticals

USA, Inc., 425 Privet

Rd., Horsham, PA 19044.

ANDA 040137......... Chlorzoxazone Tablets Do.

USP, 500 milligrams

(mg).

ANDA 040410......... Methylphenidate Do.

Hydrochloride (HCl)

Extended-Release

Tablets USP, 20 mg.

ANDA 040456......... Amphetamine Aspartate; Actavis Elizabeth, LLC,

Amphetamine Sulfate; Subsidiary of Teva

Dextroamphetamine Pharmaceuticals USA,

Saccharate; Inc., 425 Privet Rd.,

Dextroamphetamine Horsham, PA 19044.

Sulfate Tablets, 1.25

mg/1.25 mg/1.25 mg/1.25

mg, 2.5 mg/2.5 mg/2.5

mg/2.5 mg, 5 mg/5 mg/5

mg/5 mg, and 7.5 mg/7.5

mg/7.5 mg/7.5 mg.

ANDA 040666......... A-Hydrocort Hospira, Inc., a Pfizer

(hydrocortisone sodium Company, 275 North

succinate) for Field Dr., Bldg. H1,

Injection USP, Lake Forest, IL 60045.

Equivalent to (EQ) 100

mg base/vial.

ANDA 062520......... Kanamycin Sulfate Watson Laboratories,

Injection, EQ 1 gram Inc., Subsidiary of

(g) base/3 mL. Teva Pharmaceuticals

USA, Inc.

ANDA 062693......... Cephradine for Oral Teva Pharmaceuticals

Suspension USP, 125 mg/ USA, Inc., 425 Privet

5 mL and 250 mg/5 mL. Rd., Horsham, PA 19044.

ANDA 062844......... Nafcillin for Injection Watson Laboratories,

USP, EQ 500 mg base/ Inc., Subsidiary of

vial, EQ 1 g base/vial, Teva Pharmaceuticals

EQ 1.5 g base/vial, EQ USA, Inc.

2 g base/vial, and EQ 4

g base/vial.

ANDA 062856......... Oxacillin for Injection Do.

USP, EQ 250 mg base/

vial, EQ 500 mg base/

vial, EQ 1 g base/vial,

EQ 2 g base/vial, and

EQ 4 g base/vial.

ANDA 062984......... Oxacillin for Injection Do.

USP, EQ 10 g base/vial

(Pharmacy Bulk Package).

ANDA 062991......... Penicillin G Potassium Do.

for Injection USP, 1

million units/vial, 5

million units/vial, 10

million units/vial, and

20 million units/vial.

ANDA 063008......... Nafcillin for Injection Do.

USP, EQ 10 g base/vial

(Pharmacy Bulk Package).

ANDA 063014......... Penicillin G Sodium for Do.

Injection USP, 5

million units/vial.

ANDA 063106......... Gentamicin Injection Teva Pharmaceuticals

USP, EQ 40 mg base/mL. USA, Inc.

ANDA 064035......... Cefuroxime for Injection Watson Laboratories,

USP, EQ 750 mg base/ Inc., Subsidiary of

vial and EQ 1.5 g base/ Teva Pharmaceuticals

vial. USA, Inc.

ANDA 065280......... Cefazolin for Injection Cephazone Pharma, LLC,

USP, EQ 500 mg base/ 250 E. Bonita Ave.,

vial and EQ 1 g base/ Pomona, CA 91767.

vial.

ANDA 065294......... Ceftriaxone for Do.

Injection USP, EQ 250

mg base/vial, EQ 500 mg

base/vial, EQ 1 g base/

vial, and EQ 2 g base/

vial.

ANDA 065295......... Cefazolin for Injection Do.

USP, EQ 10 g base/vial

(Pharmacy Bulk Package).

ANDA 065296......... Cefazolin for Injection Do.

USP, EQ 20 g base/vial

(Pharmacy Bulk Package).

ANDA 070301......... Propranolol HCl and Watson Laboratories,

Hydrochlorothiazide Inc., Subsidiary of

Tablets USP, 40 mg/25 Teva Pharmaceuticals

mg. USA, Inc.

ANDA 070305......... Propranolol HCl and Do.

Hydrochlorothiazide

Tablets USP, 80 mg/25

mg.

ANDA 070468......... Verapamil HCl Tablets Actavis Elizabeth, LLC,

USP, 120 mg. Subsidiary of Teva

Pharmaceuticals USA,

Inc.

ANDA 070549......... Propranolol HCl Tablets Watson Laboratories,

USP, 20 mg. Inc., Subsidiary of

Teva Pharmaceuticals

USA, Inc.

ANDA 070703......... Methyldopa Tablets USP, Do.

250 mg.

ANDA 070714......... Haloperidol Injection Do.

USP, EQ 5 mg base/mL.

ANDA 070851......... Propranolol HCl and Actavis Elizabeth, LLC,

Hydrochlorothiazide Subsidiary of Teva

Tablets USP, 40 mg/25 Pharmaceuticals USA,

mg. Inc.

ANDA 070852......... Propranolol HCl and Do.

Hydrochlorothiazide

Tablets USP, 80 mg/25

mg.

ANDA 070855......... Verapamil HCl Tablets Watson Laboratories,

USP, 80 mg. Inc., Subsidiary of

Teva Pharmaceuticals

USA, Inc.

ANDA 070958......... Methyldopa and Do.

Hydrochlorothiazide

Tablets USP, 250 mg/15

mg.

ANDA 070959......... Methyldopa and Do.

Hydrochlorothiazide

Tablets USP, 250 mg/25

mg.

ANDA 070960......... Methyldopa and Do.

Hydrochlorothiazide

Tablets USP, 500 mg/50

mg.

Page 130

ANDA 071069......... Methyldopa and Do.

Hydrochlorothiazide

Tablets USP, 500 mg/30

mg.

ANDA 071110......... Lorazepam Tablets USP, 2 Do.

mg.

ANDA 071117......... Lorazepam Tablets USP, Do.

0.5 mg.

ANDA 071118......... Lorazepam Tablets USP, 1 Do.

mg.

ANDA 071485......... Doxepin HCl Capsules Do.

USP, EQ 10 mg base.

ANDA 071486......... Doxepin HCl Capsules Do.

USP, EQ 25 mg base.

ANDA 071666......... Ibuprofen Tablets, 400 Pliva, Inc., Subsidiary

mg. of Teva Pharmaceuticals

USA, Inc., 425 Privet

Rd., Horsham, PA 19044.

ANDA 071792......... Propranolol HCl Tablets Watson Laboratories,

USP, 90 mg. Inc., Subsidiary of

Teva Pharmaceuticals

USA, Inc.

ANDA 071883......... Betamethasone Valerate Teva Pharmaceuticals

Lotion USP, EQ 0.1% USA, Inc.

base.

ANDA 071919......... Nalidixic Acid Tablets Watson Laboratories,

USP, 1 g. Inc., Subsidiary of

Teva Pharmaceuticals

USA, Inc.

ANDA 071936......... Nalidixic Acid Tablets Do.

USP, 250 mg.

ANDA 072061......... Nalidixic Acid Tablets Do.

USP, 500 mg.

ANDA 072164......... Maprotiline HCl Tablets Do.

USP, 75 mg.

ANDA 072795......... Metaproterenol Sulfate Do.

Tablets USP, 20 mg.

ANDA 072824......... Baclofen Tablets USP, 10 Do.

mg.

ANDA 073373......... Morphine Sulfate Do.

Injection USP, 1 mg/2

mL (Ampule).

ANDA 073374......... Morphine Sulfate Do.

Injection USP, 10 mg/10

mL (Ampule).

ANDA 073375......... Morphine Sulfate Do.

Injection USP, 5 mg/10

mL (Vial).

ANDA 073376......... Morphine Sulfate Do.

Injection USP, 10 mg/10

mL (Vial).

ANDA 073443......... Meperidine HCl Injection Do.

USP, 10 mg/mL

(Preservative Free).

ANDA 073444......... Meperidine HCl Injection Do.

USP, 50 mg/mL.

ANDA 073529......... Doxapram HCl Injection Do.

USP, 20 mg/mL.

ANDA 074032......... Metoprolol Tartrate Do.

Injection USP, 1 mg/mL.

ANDA 074195......... Naproxen Sodium Tablets Do.

USP, EQ 250 mg base and

EQ 500 mg base.

ANDA 074276......... Lorazepam Injection USP, Do.

2 mg/mL and 4 mg/mL.

ANDA 074279......... Dobutamine.............. Do.

Injection USP, EQ 12.5

mg base/mL.

ANDA 074393......... Isoflurane USP, 99.9%... Do.

ANDA 074457......... Naproxen Tablets USP, Do.

250 mg, 375 mg, and 500

mg.

ANDA 074598......... Hydromorphone HCl Hospira, Inc.

Injection USP, 10 mg/mL.

ANDA 074864......... Ranitidine Tablets USP, Watson Laboratories,

EQ 150 mg base and EQ Inc., Subsidiary of

300 mg base. Teva Pharmaceuticals

USA, Inc.

ANDA 074906......... Acyclovir Capsules USP, Actavis Elizabeth, LLC,

200 mg. Subsidiary of Teva

Pharmaceuticals USA,

Inc.

ANDA 075253......... Ticlopidine HCl Tablets, Do.

250 mg.

ANDA 075650......... Famotidine Tablets USP, Do.

20 mg and 40 mg.

ANDA 075672......... Bisoprolol Fumarate and Do.

Hydrochlorothiazide

Tablets, 2.5 mg/6.25

mg, 5 mg/6.25 mg, and

10 mg/6.25 mg.

ANDA 075843......... Oxaprozin Tablets, 600 Do.

mg.

ANDA 075901......... Fluvoxamine Maleate Do.

Tablets, 25 mg, 50 mg,

and 100 mg.

ANDA 075960......... Tramadol HCl Tablets, 50 Do.

mg.

ANDA 076689......... Mirtazapine Orally Do.

Disintegrating Tablets

USP, 15 mg, 30 mg, and

45 mg.

ANDA 077174......... Foscarnet Sodium Hospira, Inc.

Injection, 2.4 g/100 mL.

ANDA 077963......... Granisetron HCl Teva Pharmaceuticals

Injection, EQ 1 mg base/ USA, Inc.

mL.

ANDA 080615......... Dimenhydrinate Watson Laboratories,

Injection, 50 mg/mL. Inc., Subsidiary of

Teva Pharmaceuticals

USA, Inc.

ANDA 080713......... Tripelennamine HCl Do.

Tablets USP, 50 mg.

ANDA 081150......... Hydroxyzine HCl Tablets Do.

USP, 25 mg.

ANDA 081151......... Hydroxyzine HCl Tablets Do.

USP, 50 mg.

ANDA 083287......... Procainamide HCl Do.

Capsules USP, 250 mg.

ANDA 084280......... Procainamide HCl Do.

Capsules USP, 500 mg.

ANDA 084403......... Procainamide HCl Do.

Capsules USP, 375 mg.

ANDA 084467......... Reserpine and Do.

Hydrochlorothiazide

Tablets USP, 0.125 mg/

50 mg.

ANDA 085083......... Diphenhydramine HCl Do.

Capsules USP, 50 mg.

ANDA 085140......... Quinidine Sulfate Do.

Tablets USP, 200 mg.

ANDA 085173......... Chlorothiazide Tablets Do.

USP, 250 mg.

ANDA 085180......... Methocarbamol Tablets Do.

USP, 500 mg.

ANDA 085192......... Methocarbamol Tablets Do.

USP, 750 mg.

ANDA 085597......... Methylprednisolone Do.

Acetate Injectable

Suspension USP, 20 mg/

mL.

ANDA 086013......... Statobex Teva Pharmaceuticals

(phendimetrazine USA, Inc.

tartrate) Tablets USP,

35 mg.

ANDA 086029......... Testosterone Cypionate Watson Laboratories,

Injection USP, 100 mg/ Inc., Subsidiary of

mL. Teva Pharmaceuticals

USA, Inc.

ANDA 086031......... Isosorbide Dinitrate Do.

Sublingual Tablets USP,

5 mg.

Page 131

ANDA 086034......... Isosorbide Dinitrate Do.

Tablets USP, 5 mg.

ANDA 086188......... Gerimal (ergoloid Do.

mesylates) Sublingual

Tablets, 1 mg.

ANDA 086385......... Nandrolone Decanoate Do.

Injection, 50 mg/mL.

ANDA 086562......... Wigraine (ergotamine Organon USA, Inc.,

tartrate and caffeine) Subsidiary of Merck &

Tablets USP, 1 mg/100 Co., Inc., 2000

mg. Galloping Hill Rd.,

Kenilworth, NJ 07033.

ANDA 086742......... Choledyl SA Warner Chilcott Co.,

(oxtriphylline) LLC, Subsidiary of Teva

Extended-Release Pharmaceuticals USA,

Tablets, 600 mg. Inc., 425 Privet Rd.,

Horsham, PA 19044.

ANDA 086863......... Chlorpromazine HCl Oral Actavis Mid Atlantic,

Concentrate USP, 100 mg/ LLC, Subsidiary of Teva

mL. Pharmaceuticals USA,

Inc., 425 Privet Rd.,

Horsham, PA 19044.

ANDA 087233......... Ergoloid Mesylates Watson Laboratories,

Sublingual Tablets USP, Inc., Subsidiary of

0.5 mg. Teva Pharmaceuticals

USA, Inc.

ANDA 087244......... Ergoloid Mesylates Do.

Tablets USP, 1 mg.

ANDA 087318......... Tolbutamide Tablets USP, Do.

500 mg.

ANDA 087727......... Aminophylline Oral Actavis Mid Atlantic,

Solution USP, 105 mg/5 LLC, Subsidiary of Teva

mL (Dye Free). Pharmaceuticals USA,

Inc.

ANDA 088128......... Nandrolone Decanoate Watson Laboratories,

Injection, 200 mg/mL. Inc., Subsidiary of

Teva Pharmaceuticals

USA, Inc.

ANDA 088337......... Ergostat (ergotamine Do.

tartrate) Sublingual

Tablets USP, 2 mg.

ANDA 088477......... Thioridazine HCl Tablets Do.

USP, 15 mg.

ANDA 088561......... Thioridazine HCl Tablets Do.

USP, 10 mg.

ANDA 088564......... Thioridazine HCl Tablets Do.

USP, 100 mg.

ANDA 088724......... Methyclothiazide Tablets Do.

USP, 5 mg.

ANDA 088734......... Meclizine HCl Tablets, Pliva, Inc., Subsidiary

25 mg. of Teva Pharmaceuticals

USA, Inc.

ANDA 088769......... Mepivacaine HCl Watson Laboratories,

Injection USP, 1%. Inc., Subsidiary of

Teva Pharmaceuticals

USA, Inc.

ANDA 088770......... Mepivacaine HCl Do.

Injection USP, 2%.

ANDA 088872......... Thioridazine HCl Tablets Do.

USP, 200 mg.

ANDA 089026......... Procainamide HCl Do.

Extended-Release

Tablets USP, 250 mg.

ANDA 089027......... Procainamide HCl Do.

Extended-Release

Tablets USP, 500 mg.

ANDA 089530......... Prochlorperazine Do.

Edisylate Injection

USP, EQ 5 mg base/mL.

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Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of February 1, 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 table 1 that are in inventory on the date that this notice becomes effective (see DATES) 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: December 26, 2017.

Leslie Kux,

Associate Commissioner for Policy.

FR Doc. 2017-28254 Filed 12-29-17; 8:45 am

BILLING CODE 4164-01-P