Document ID: FDA-2022-N-3012-0001
Agency: fda
Document Type: Notice
Title: Teva Branded Pharmaceutical Products R and D, Inc., et al.; Withdrawal of Approval of 35 New Drug Applications
Posted Date: 2022-12-08T05:00Z

[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]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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applications be withdrawn.

DATES: Approval is withdrawn as of January 9, 2023.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.

------------------------------------------------------------------------
      Application No.                  Drug                Applicant
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

[[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