Document ID: FDA-2021-N-1071-0001
Agency: fda
Document Type: Notice
Title: Allergan Sales, LLC, et al.; Withdrawal of Approval of 18 New Drug Applications
Posted Date: 2021-11-01T04:00Z

[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60251-60252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23729]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1071]

Allergan Sales, LLC, et al.; Withdrawal of Approval of 18 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 18 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applications be withdrawn.

DATES: Approval is withdrawn as of December 1, 2021.

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.

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 007409.............  Bentyl (dicyclomine      Allergan Sales, LLC, 5
                          hydrochloride (HCl))     Giralda Farms,
                          Capsules, 10 milligram   Madison, NJ 07940.
                          (mg).
                         Bentyl (dicyclomine
                          HCl) Tablets, 20 mg.
NDA 013625.............  Norinyl 1 + 50           Actavis Laboratories
                          (norethindrone and       UT, Inc. (an
                          mestranol) Tablets,      indirect, wholly
                          0.05 mg/1 mg.            owned subsidiary of
                         Norinyl (norethindrone    Teva Pharmaceuticals
                          and mestranol)           USA, Inc.), 145
                          Tablets, 0.1 mg/2 mg.    Brandywine Pkwy.,
                                                   West Chester, PA
                                                   19380.
NDA 014169.............  Dendrid (idoxuridine)    Alcon Laboratories,
                          Ophthalmic Solution,     Inc., 6201 South
                          0.1%.                    Freeway, Fort Worth,
                                                   TX 76134.
NDA 019404.............  Ocufen (flurbiprofen     Allergan, Inc., 2525
                          sodium) Ophthalmic       Dupont Dr., Irvine,
                          Solution, 0.03%.         CA 92612.
NDA 019784.............  Ibuprofen Oral           Abbott Laboratories
                          Suspension, 100 mg/5     Established
                          milliliters (mL).        Pharmaceuticals
                                                   Products Division,
                                                   200 Abbott Park Rd.,
                                                   Abbott Park, IL
                                                   60064.
NDA 020010.............  Lotrisone                Merck Sharp and Dohme
                          (betamethasone           Corp., a subsidiary
                          dipropionate and         of Merck and Co.,
                          clotrimazole) Lotion,    Inc., 1 Merck Drive,
                          Equivalent to (EQ)       P.O. Box 100,
                          0.05% base/1%.           Whitehouse Station,
                                                   NJ 08889.
NDA 020098.............  Mivacron (mivacurium     AbbVie, Inc., 1 N
                          chloride) Solution, EQ   Waukegan Rd., North
                          2 mg base/mL, EQ 10 mg   Chicago, IL 60064
                          base/5 mL, and EQ 20
                          mg base/10 mL.
                         Mivacron in Dextrose 5%
                          in plastic container
                          (mivacurium chloride)
                          Injectable, EQ 0.5 mg
                          base/mL and EQ 50 mg
                          base/100 mL.
NDA 020412.............  Zerit (stavudine)        Bristol-Myers Squibb
                          Capsules, 5 mg, 15 mg,   Co., P.O. Box 4000,
                          20 mg, 30 mg, and 40     Princeton, NJ 08543.
                          mg.

[[Page 60252]]

 
NDA 020509.............  Gemzar (gemcitabine      Eli Lilly and Co.,
                          HCl) Injection, EQ 200   Lilly Corporate
                          mg base and EQ 1 gram    Center, Indianapolis,
                          (g) base.                IN 46285.
NDA 020696.............  Antizol (fomepizole)     Par Sterile Products,
                          Injection, 1.5 g/1.5     LLC, 6 Ram Ridge Rd.,
                          mL.                      Chestnut Ridge, NY
                                                   10977.
NDA 020705.............  Rescriptor (delavirdine  ViiV Healthcare Co., 5
                          mesylate) Tablets, 100   Moore Dr., Research
                          mg and 200 mg.           Triangle Park, NC
                                                   27709.
NDA 021114.............  Betaxon (levobetaxolol   Alcon Laboratories,
                          HCl) Ophthalmic          Inc.
                          Suspension, EQ 0.5%
                          base.
NDA 021199.............  Quixin (levofloxacin)    Santen Inc., 6401
                          Ophthalmic Solution,     Hollis St., Suite
                          0.5%.                    125, Emeryville, CA
                                                   94608.
NDA 021571.............  Iquix (levofloxacin)      Do.
                          Ophthalmic Solution,
                          1.5%.
NDA 050704.............  DaunoXome (daunorubicin  Galen Limited, 25
                          citrate liposome         Fretz Rd., Souderton,
                          injection), EQ 2 mg      PA 18964.
                          base/mL.
NDA 204736.............  AcipHex Sprinkle         Aytu BioScience Inc.,
                          (rabeprazole sodium)     373 Inverness
                          Delayed Release          Parkway, Suite 206,
                          Capsules, 5 mg and 10    Englewood, CO 80112.
                          mg.
NDA 205060.............  Epanova (omega-3-        AstraZeneca
                          carboxylic acids)        Pharmaceuticals LP,
                          Capsules, 1 gram (1 g    1800 Concord Pike,
                          contains at least 850    Wilmington, DE 19803.
                          mg of polyunsaturated
                          fatty acids).
NDA 206843.............  Daklinza (daclatasvir    Bristol-Myers Squibb
                          dihydrochloride)         Co.
                          Tablets, EQ 30 mg
                          base, EQ 60 mg base,
                          and EQ 90 mg base.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
December 1, 2021. Approval of each entire application is withdrawn, 
including any strengths and dosage forms 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 December 1, 2021 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: October 25, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23729 Filed 10-29-21; 8:45 am]
BILLING CODE 4164-01-P