[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46079-46081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21177]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-4563]
Johnson & Johnson Consumer Inc. et al.; Withdrawal of Approval of
7 New Drug Applications and 71 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 7 new drug applications (NDAs) and 71 abbreviated new drug
applications (ANDAs) from multiple
[[Page 46080]]
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that the approval of the applications be withdrawn.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: Withdrawal of approval is effective November 2, 2017.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.
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 pursuant to 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.
----------------------------------------------------------------------------------------------------------------
Application No. Drug Applicant
----------------------------------------------------------------------------------------------------------------
NDA 014349.............................. Delfen (nonoxynol-9) Johnson & Johnson Consumer Inc., 199
Contraceptive Foam, 12.5%. Grandview Rd., Skillman, NJ 08558.
ANDA 019346............................. Dextrose 60% Injection USP in Hospira, Inc., 275 North Field Dr.,
Plastic Container. Dept. 389, Bldg. H2-2, Lake Forest,
IL 60045.
NDA 019810.............................. Prilosec (omeprazole) Delayed- AstraZeneca Pharmaceuticals LP, One
Release Capsules, 10 milligrams MedImmune Way, Gaithersburg, MD
(mg), 20 mg, and 40 mg. 20878.
NDA 020184.............................. Aceon (perindopril erbumine) Symplmed Pharmaceuticals, LLC, 5375
Tablets, 2 mg, 4 mg, and 8 mg. Medspace Way, Cincinnati, OH 45227.
NDA 022345.............................. Potiga (ezogabine) Tablets, 50 GlaxoSmithKline Intellectual
mg, 200 mg, 300 mg, and 400 mg. Property Management LTD England, c/
o GlaxoSmithKline, 1250 South
Collegeville Road, P.O. Box 5089,
Collegeville, PA 19426.
NDA 021712.............................. Fluxid (famotidine) Orally UCB, Inc., 1950 Lake Park Dr., Bldg.
Disintegrating Tablets, 20 mg 2100, Smyrna, GA 30080.
and 40 mg.
ANDA 040108............................. Acetazolamide for Injection USP, Hospira, Inc.
Equivalent to (EQ) 500 mg base/
vial.
ANDA 040206............................. Digoxin Injection USP, 0.25 mg/ Do.
milliliter (mL).
ANDA 040527............................. Phentermine Hydrochloride (HCl) Sun Pharmaceutical Industries, Inc.,
Capsules USP, 37.5 mg. 270 Prospect Plains Rd., Cranbury,
NJ 08512.
ANDA 040899............................. Hydroxyzine HCl Tablets USP, 10 Do.
mg, 25 mg, and 50 mg.
ANDA 060099............................. Penicillin G Procaine for Pfizer Inc., 235 East 42nd St., New
Injection, 300,000 units/vial York, NY 10017.
and 1,500,000 units/vial.
ANDA 063161............................. Tobramycin Injection USP, EQ 40 Hospira, Inc.
mg base/mL.
ANDA 070171............................. Naloxone HCl Injection USP, 0.02 Do.
mg/mL.
ANDA 070186............................. Disopyramide Phosphate Capsules Ivax Pharmaceuticals, Inc.,
USP, EQ 100 mg base. Subsidiary of Teva Pharmaceuticals
USA, Inc., 425 Privet Rd., Horsham,
PA 19044.
ANDA 070233............................. Propranolol HCl Tablets USP, 20 Teva Pharmaceuticals USA, Inc., 425
mg. Privet Rd., Horsham, PA 19044.
ANDA 070255............................. Naloxone HCl Injection, 0.4 mg/ Hospira, Inc.
mL.
ANDA 070698............................. Methyldopate HCl Injection USP, Do.
50 mg/mL, ADD-Vantage Vial.
ANDA 070699............................. Methyldopate HCl Injection USP, Do.
50 mg/mL, Fliptop Vial.
ANDA 070739............................. Verapamil HCl Injection, 2.5 mg/ Do.
mL, 2 mL Abbojet-PA Syringe.
ANDA 070740............................. Verapamil HCl Injection, 2.5 mg/ Do.
mL, 4 mL Abbojet Syringe Vial.
ANDA 070803............................. Enflurane USP, 99.9%............ Abbott Laboratories, Hospital
Products Division, 200 Abbott Park
Rd., D389, Bldg. J45-2, Abbott
Park, IL 60064.
ANDA 070888............................. Aminocaproic Acid Injection USP, Hospira, Inc.
250 mg/mL.
ANDA 071357............................. Tolazamide Tablets USP, 100 mg.. Sun Pharmaceutical Industries, Inc.
ANDA 071438............................. Ritodrine HCl in Dextrose 5% Hospira, Inc.
Injection, 30 mg/100 mL.
ANDA 071618............................. Ritodrine HCl Injection USP, 10 Do.
mg/mL.
ANDA 071619............................. Ritodrine HCl Injection USP, 15 Do.
mg/mL.
ANDA 071982............................. Droperidol and Fentanyl Citrate Do.
Injection, 2.5 mg/mL and EQ
0.05 mg base/mL.
ANDA 072321............................. Pancuronium Bromide Injection, 2 Do.
mg/mL.
ANDA 073199............................. Sulfamethoxazole and Do.
Trimethoprim Injection USP, 80
mg/mL and 16 mg/mL.
ANDA 073310............................. Tolmetin Sodium Tablets USP, EQ Sun Pharmaceutical Industries, Inc.
200 mg base.
ANDA 073428............................. CO-LAV (polyethylene glycol 3350 Vintage Pharmaceuticals, 150 Vintage
and electrolytes) for Oral Dr., Huntsville, AL 35811.
Suspension.
ANDA 073433............................. GO-EVAC (polyethylene glycol Do.
3350 and electrolytes) for Oral
Suspension.
ANDA 073677............................. Carbastat (carbachol) Novartis Pharmaceuticals Corp., One
Intraocular Solution, 0.01%. Health Plaza, East Hanover, NJ
07936.
ANDA 074168............................. Diltiazem HCl Tablets USP, 30 Ivax Pharmaceuticals, Inc.,
mg, 60 mg, 90 mg, and 120 mg. Subsidiary of Teva Pharmaceuticals
USA, Inc.
ANDA 074280............................. Lorazepam Injection USP, 2 mg/mL Hospira, Inc.
and 4 mg/mL.
ANDA 074296............................. Cimetidine HCl Injection, EQ 300 Do.
mg base/2 mL (Carpuject).
ANDA 074412............................. Cimetidine HCl Injection, EQ 300 Do.
mg base/2 mL.
ANDA 074422............................. Cimetidine HCl Injection, EQ 300 Do.
mg base/2 mL, ADD-Vantage Vial.
ANDA 074468............................. Cimetidine HCl in Sodium Do.
Chloride 0.9% Injection in
Plastic Container, EQ 90 mg
base/100 mL, EQ 120 mg base/100
mL, EQ 180 mg base/100 mL, EQ
240 mg base/100 mL, EQ 360 mg/
100 mL, and EQ 480 mg base/100
mL.
ANDA 074620............................. Butorphanol Tartrate Injection Do.
USP, 1 mg/mL and 2 mg/mL.
ANDA 074758............................. Acyclovir for Injection USP, EQ Do.
500 mg base/vial and EQ 1 gram
(g) base/vial.
[[Page 46081]]
ANDA 074801............................. Ketorolac Tromethamine Injection Do.
USP, 15 mg/mL and 30 mg/mL.
ANDA 075385............................. Buspirone HCl Tablets USP, 5 mg, Ivax Pharmaceuticals, Inc.,
10 mg, and 15 mg. Subsidiary of Teva Pharmaceuticals
USA, Inc.
ANDA 075453............................. Doxazosin Tablets USP, EQ 1 mg Do.
base, EQ 2 mg base, EQ 4 mg
base, and EQ 8 mg base.
ANDA 076883............................. Sotalol HCl Tablets USP, 80 mg, Teva Pharmaceuticals USA, Inc.
120 mg, and 160 mg.
ANDA 077052............................. Citalopram Hydrobromide Tablets, Sun Pharmaceutical Industries, Inc.
EQ 10 mg base, EQ 20 mg base,
and EQ 40 mg base.
ANDA 077937............................. Meloxicam Tablets, 7.5 mg and 15 Do.
mg.
ANDA 078081............................. Amlodipine Besylate Tablets, EQ Do.
2.5 mg base, EQ 5 mg base, and
EQ 10 mg base.
ANDA 078158............................. Fosphenytoin Sodium Injection Hospira, Inc.
USP, EQ 50 mg Phenytoin Soudium/
mL.
ANDA 078483............................. Zolpidem Tartrate Extended- Synthon Pharmaceuticals, Inc., 1007
Release Tablets USP, 6.25 mg Slater Rd., Suite 150, Durham, NC
and 12.5 mg. 27703.
ANDA 080136............................. Isoniazid Tablets, 100 mg....... Sun Pharmaceutical Industries, Inc.
ANDA 080209............................. Prednisone Tablets USP, 5 mg.... Contract Pharmacal Corp., c/o
SciRegs International Inc., 6333
Summercrest Dr., Columbia, MD
21045.
ANDA 080224............................. Sorbitol; Mannitol Irrigation Hospira, Inc.
Solution, 2.7 g/100 mL; 540 mg/
100 mL.
ANDA 083345............................. Potassium Chloride for Injection Do.
Concentrate USP, 1
milliequivalent (mEQ)/mL, 1.5
mEQ/mL, and 2 mEQ/mL.
ANDA 083808............................. Quinidine Sulfate Tablets USP, Contract Pharmacal Corp., c/o
200 mg. SciRegs International Inc.
ANDA 084623............................. Chlordiazepoxide HCl Capsules Upsher-Smith Laboratories, Inc.,
USP, 10 mg. 6701 Evenstad Dr., Maple Grove, MN
55369.
ANDA 084644............................. Chlordiazepoxide HCl Capsules Do.
USP, 5 mg.
ANDA 084710............................. Ogen (estropipate) Vaginal Cream Pfizer Inc.
USP, 1.5 mg/g.
ANDA 085061............................. Folic Acid Tablets USP, 1 mg.... Contract Pharmacal Corp., c/o
SciRegs International Inc.
ANDA 085933............................. Phentermine HCl Tablets USP..... Lemmon Co., 650 Cathill Rd.,
Sellersville, PA 18960.
ANDA 086494............................. Chlordiazepoxide HCl Capsules, Teva Pharmaceuticals USA, Inc.
25 mg.
ANDA 086821............................. Hydroxyzine HCl Injection USP, Hospira, Inc.
50 mg/mL.
ANDA 087416............................. Hydroxyzine HCl Injection USP, Do.
25 mg/mL, Carpuject.
ANDA 087546............................. Hydroxyzine HCl Injection USP, Do.
50 mg/mL, Carpuject.
ANDA 087862............................. Hydroxyzine HCl Tablets USP, 100 Sun Pharmaceutical Industries, Inc.
mg.
ANDA 088147............................. Aminophylline in Sodium Chloride Hospira, Inc.
0.45% Injection, 100 mg/100 mL
and 200 mg/100 mL.
ANDA 088367............................. Lidocaine HCl Injection USP, 10% Do.
ANDA 088542............................. Lidocaine HCl Injection USP, 4%. Do.
ANDA 089162............................. Cyclopentolate HCl Ophthalmic Alcon Pharmaceuticals, Ltd., 6201
Solution, 1%. South Freeway TC-45, Fort Worth, TX
76134.
ANDA 089347............................. Diatrizoate Meglumine and Bracco Diagnostics Inc., 259
Diatrizoate Sodium Injection Prospect Plains Rd., Bldg. H,
USP, 66%; 10%. Monroe Township, NJ 08831.
ANDA 089393............................. Glycopyrrolate Injection USP, Hospira, Inc.
0.2 mg/mL.
ANDA 089488............................. Diphenhydramine HCl Capsules, 25 Sun Pharmaceutical Industries, Inc.
mg.
ANDA 089521............................. Phenytoin Sodium Injection USP, Hospira, Inc.
50 mg/mL, Ampule.
ANDA 089537............................. Procainamide HCl Injection USP, Do.
500 mg/mL, Carpuject.
ANDA 089744............................. Phenytoin Sodium Injection USP, Do.
50 mg/mL, Carpuject.
ANDA 089915............................. Leucovorin Calcium for Pharmachemie B.V., c/o SICOR
Injection, EQ 100 mg base/vial. Pharmaceuticals, Inc., 19 Hughes,
Irvine, CA 92618.
NDA 202258.............................. Victrelis (boceprevir) Capsules, Merck Sharp & Dohme Corp.,
200 mg. Subsidiary of Merck & Company,
Inc., 1 Merck Dr., P.O. Box 100,
Whitehouse Station, NJ 08889.
NDA 203093.............................. Vitekta (elvitegravir) Tablets, Gilead Sciences, Inc., 333 Lakeside
85 mg and 150 mg. Dr., Foster City, CA 94404.
----------------------------------------------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn, effective
November 2, 2017. 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 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: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21177 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P