[Federal Register Volume 87, Number 235 (Thursday, December 8, 2022)]
[Notices]
[Pages 75276-75278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26661]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-3012]
Teva Branded Pharmaceutical Products R and D, Inc., et al.;
Withdrawal of Approval of 35 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 35 new drug applications (NDAs) from multiple
applicants. The applicants 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applications be withdrawn.
DATES: Approval is withdrawn as of January 9, 2023.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].
SUPPLEMENTARY INFORMATION: The applicants 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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NDA 006536................. Urecholine (bethanechol Teva Branded
chloride) Injection, 5 Pharmaceutical
milligram (mg)/ Products R and D,
milliliter (mL). Inc., 145
Urecholine (bethanechol Brandywine Pkwy.,
chloride) Tablets, 5 West Chester, PA
mg, 10 mg, 25 mg, and 19380.
50 mg.
NDA 011707................. Opana (oxymorphone Endo
hydrochloride (HCl)) Pharmaceuticals,
Injection, 1 mg/mL and Inc., 1400
1.5 mg/mL. Atwater Dr.,
Malvern, PA
19355.
[[Page 75277]]
NDA 012209................. Fluorouracil Injection, Spectrum
500 mg/10 mL and 2.5 Pharmaceuticals,
grams (g)/50 mL. Inc., 157
Technology Dr.,
Irvine, CA 92618.
NDA 016772................. Resectisol in plastic B. Braun Medical
container (mannitol) Inc., 901 Marcon
Solution for Blvd., Allentown,
Irrigation, 5 g/100 mL. PA 18109-9341.
NDA 017354................. Loestrin Fe 1/20 Teva Branded
(ethinyl estradiol and Pharmaceutical
norethindrone acetate) Products R and D,
Tablets, 0.02 mg/1 mg. Inc.
NDA 017355................. Loestrin Fe 1.5/30 Do.
(ethinyl estradiol and
norethindrone acetate)
Tablets, 0.03 mg/1.5
mg).
NDA 017716................. Ovcon-35 (ethinyl Warner Chilcott
estradiol and Co., LLC, c/o
norethindrone) 28-Day Warner Chilcott
Tablets, 0.035 mg/0.4 (U.S.) LLC, 100
mg. Enterprise Dr.,
NJ 07866.
NDA 017875................. Loestrin 1.5/30 Teva Branded
(ethinyl estradiol and Pharmaceutical
norethindrone acetate) Products R and D,
21-Day Tablets, 0.03 Inc.
mg/1.5 mg.
NDA 017876................. Loestrin 1/20 (ethinyl Do.
estradiol and
norethindrone acetate)
21-Day Tablets, 0.02
mg/1 mg.
NDA 018127................. Ovcon-35 (ethinyl Warner Chilcott
estradiol and Co., LLC, c/o
norethindrone) 21-Day Warner Chilcott
Tablets, 0.035 mg/0.4 (U.S.) LLC.
mg.
NDA 018238................. Micro-K (potassium Nesher
chloride) Extended- Pharmaceuticals
release Capsules, 8 USA, LLC, 13910
milliequivalents (mEQ). Saint Charles
Micro-K 10 (potassium Rock Rd.,
chloride) Extended- Bridgeton, MO
release Capsules, 10 63044.
mEQ.
NDA 018405................. Aygestin (norethindrone Teva Branded
acetate) Tablets, 5 mg. Pharmaceutical
Products R&D,
Inc.
NDA 018603................. Zovirax (acyclovir GlaxoSmithKline
sodium) for Injection, LLC, 2929 Walnut
equivalent to (EQ) 250 St., Suite 1700,
mg base/vial, EQ 500 Philadelphia, PA
mg base/vial, and EQ 1 19104.
g base/vial.
NDA 018764................. Metronidazole Tablets, Watson
250 mg and 500 mg. Laboratories,
Inc., an
indirect, wholly
owned subsidiary
of Teva
Pharmaceuticals
USA, Inc., 400
Interpace Pkwy.,
Parsippany, NJ
07054.
NDA 018796................. Pilopine HS Alcon
(pilocarpine HCl) Laboratories,
Ophthalmic Gel, 4%. Inc., 6201 South
Freeway, Fort
Worth, TX 76134-
2099.
NDA 019211................. Theophylline in Hospira, Inc., 275
Dextrose 5% in plastic North Field Dr.,
containers, Injection, Bldg. HI-3S, Lake
4 mg/mL, 40 mg/100 mL, Forest, IL 60045.
80 mg/100 mL, 160 mg/
100 mL, 200 mg/100 mL,
320 mg/100 mL, and 400
mg/100 mL.
NDA 019926................. Hexalen (altretamine) Eisai, Inc., 155
Capsules, 50 mg. Tice Blvd.,
Woodcliff Lake,
NJ 07611.
NDA 020130................. Estrostep Fe (ethinyl Allergan
estradiol and Pharmaceuticals
norethindrone acetate) International
Tablets, (white Ltd., c/o
triangle) Tablets, Allergan Sales,
0.02 mg ethinyl LLC, 5 Giralda
estradiol and 1 mg Farms, Madison,
norethindrone acetate; NJ 07940.
(white square)
Tablets, 0.03 mg
ethinyl estradiol and
1 mg norethindrone
acetate; (white round)
Tablets, 0.035 mg
ethinyl estradiol and
1 mg norethindrone
acetate.
Estrostep 21 (ethinyl
estradiol and
norethindrone acetate)
Tablets, (white
triangle) Tablets,
0.02 mg ethinyl
estradiol and 1 mg
norethindrone acetate;
(white square)
Tablets, 0.03 mg
ethinyl estradiol and
1 mg norethindrone
acetate; and (white
round) Tablets, 0.035
mg ethinyl estradiol
and 1 mg norethindrone
acetate.
NDA 020667................. Mirapex (pramipexole Boehringer
dihydrocholoride) Ingelheim
Tablets, 0.125 mg, Pharmaceuticals,
0.25 mg, 0.5 mg, 0.75 Inc., 900
mg, 1 mg, 1.25 mg, and Ridgebury Rd.,
1.5 mg. P.O. Box 368,
Ridgefield, CT
06877.
NDA 020713................. Mircette (ethinyl Teva Branded
estradiol; desogestrel Pharmaceutical
and ethinyl estradiol) Products R and D,
Tablets, (yellow) Inc.
Tablets, 0.01 mg
ethinyl estradiol and
(white) Tablets, 0.15
mg desogestrel and
0.02 mg ethinyl
estradiol.
NDA 020903................. Rebetol (ribavirin) Merck Sharp and
Capsules, 200 mg. Dohme Corp., a
Rebetol (ribavirin) subsidiary of
Capsules, 200 mg Merck & Co.,
(comarketed as Inc., 126 East
Rebetron Combination Lincoln Ave.,
Therapy with P.O. Box 2000,
Interferon ALFA-2B, Rahway, NJ 07065.
Recombinant (INTRON
A)).
NDA 021200................. Zelnorm (tegaserod Alfasigma USA,
maleate) Tablets, EQ 2 Inc., 550 Hills
mg base and EQ 6 mg Dr., Suite 110B,
base. Bedminster, NJ
07921.
NDA 021546................. Rebetol (rivavirin) Merck Sharp and
Oral Solution, 40 mg/ Dohme Corp., a
mL. subsidiary of
Merck & Co., Inc.
NDA 021858................. Boniva (ibandronate Hoffmann La Roche
sodium) Injection, EQ Inc., c/o
3 mg base/3 mL. Genentech, Inc.,
1 DNA Way, South
San Francisco, CA
94080-4900.
NDA 021871................. Loestrin 24 Fe (ethinyl Teva Branded
estradiol and Pharmaceutical
norethindrone acetate Products R and D,
tablets, 0.02 mg/1mg; Inc.
and ferrous fumarate
tablets, 75 mg).
NDA 022266................. Onsolis (fentanyl Adalvo Limited c/o
citrate) Buccal Film, Biotech Research
EQ 0.2 mg base, EQ 0.4 Group, 3810 Gunn
mg base, EQ 0.6 mg Highway, Tampa,
base, EQ 0.8 mg base, FL 33618.
and EQ 1.2 mg base.
NDA 022569................. Lazanda (fentanyl BTcP Pharma LLC, c/
citrate) Nasal Spray, o West
EQ 0.1 mg base, EQ 0.3 Therapeutic
mg base, and EQ 0.4 mg Development, LLC,
base. 1033 Skokie
Blvd., Suite 620,
Northbrook, IL
60062.
NDA 040024................. Dexferrum (ferric American Regent,
oxyhydroxide) Inc., 5 Ramsey
Injection, EQ 50 mg Rd., Shirley, NY
iron/mL. 11967.
NDA 202342................. Esomeprazole Strontium Belcher
Delayed-release Pharmatech, LLC,
Capsules, 24.65 mg and 6911 Bryan Dairy
49.3 mg. Rd., Suite 220,
Largo, FL 33777.
NDA 202788................. Subsys (fentanyl) BTcP Pharma LLC, c/
Sublingual Spray, 0.1 o West
mg, 0.2 mg, 0.4 mg, Therapeutic
0.6 mg, 0.8 mg, 1.2 Development, LLC.
mg, and 1.6 mg.
NDA 204325................. Adzenys ER Neos Therapeutics
(amphetamine) Extended- Brands, Inc.,
release Oral 2940 N Highway
Suspension, EQ 1.25 mg 360, Suite 400,
base/mL. Grand Prairie, TX
75050.
NDA 205637................. Bunavail (buprenorphine BioDelivery
HCl and naloxone HCl) Sciences
Buccal Film, EQ 2.1 mg International,
base/EQ 0.3 mg base, Inc., 4131 Park
EQ 4.2 mg base/EQ 0.7 Lake Ave.,
mg base, and EQ 6.3 mg Raleigh, NC
base/EQ 1 mg base. 27612.
NDA 210045................. Consensi (amlodipine Purple Biotech
besylate and LTD, 2520
celecoxib) Tablets, EQ Meridian Pkwy.,
2.5 mg base/200 mg, EQ Suite 200,
5 mg base/200 mg, and Durham, NC 27713.
EQ 10 mg base/200 mg.
NDA 211281................. Pizensy (lactitol) Oral Braintree
Solution, 10 g. Laboratories,
Inc., 60
Columbian St.
West, Braintree,
MA 02184.
NDA 212038................. Adhansia XR Purdue Pharma
(methylphenidate HCl) L.P., One
Extended-release Stamford Forum,
Capsules, 25 mg, 35 201 Tresser
mg, 45 mg, 55 mg, 70 Blvd., Stamford,
mg, and 85 mg. CT 06901-3431.
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[[Page 75278]]
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 9, 2023. Approval of each entire application is withdrawn,
including any strengths and dosage forms included in the application
but inadvertently missing from the table. 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 January 9, 2023 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 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26661 Filed 12-7-22; 8:45 am]
BILLING CODE 4164-01-P