Document ID: FDA-2019-N-3658-0001
Agency: fda
Document Type: Notice
Title: Eli Lilly and Co., et al.; Withdrawal of Approval of 25 New Drug Applications
Posted Date: 2019-09-09T04:00Z

[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Notices]
[Pages 47309-47310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19348]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3658]

Eli Lilly and Co., et al.; Withdrawal of Approval of 25 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 25 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applications be withdrawn.

DATES: Approval is withdrawn as of October 9, 2019.

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 007529.................  Quinidine Gluconate    Eli Lilly and Co.,
                              Injection, 80          Lilly Corporate
                              milligrams (mg)/       Center,
                              milliliters (mL).      Indianapolis, IN
                                                     46285.
NDA 016096.................  Mintezol               Merck Sharp and
                              (thiabendazole)        Dohme Corp., a
                              Chewable Tablet, 500   subsidiary of Merck
                              mg.                    and Co., Inc., 1
                                                     Merck Dr., P.O. Box
                                                     100, Whitehouse
                                                     Station, NJ 08889-
                                                     0100.
NDA 016097.................  Mintezol               Do.
                              (thiabendazole)
                              Suspension 500 mg/5
                              mL.
NDA 017439.................  Hydroxyprogesterone    Allergan Sales,
                              Caproate Injection,    LLC., 5 Giralda
                              125 mg/mL and 250 mg/  Farms, Madison, NJ
                              mL.                    07940.
NDA 017831.................  Didronel (etidronate   Allergan
                              disodium) Tablet,      Pharmaceuticals
                              200 mg and 400 mg.     International
                                                     Limited, c/o
                                                     Allergan Sales,
                                                     LLC., 2525 Dupont
                                                     Dr., Irvine, CA
                                                     92612.
NDA 019081.................  Estraderm (estradiol   Novartis
                              transdermal system),   Pharmaceuticals
                              0.05 mg/24 hour (h)    Corp., 1 Health
                              and 0.1 mg/24 h.       Plaza, East
                                                     Hanover, NJ 07936-
                                                     1080.
NDA 019596.................  Magnevist              Bayer HealthCare
                              (gadopentetate         Pharmaceuticals,
                              dimeglumine)           Inc., 100 Bayer
                              Injection, 469.01 mg/  Blvd., P.O. Box
                              mL.                    915, Whippany, NJ
                                                     07981-0915.
NDA 020071.................  Desogen (desogestrel   Organon USA, Inc., a
                              and ethinyl            subsidiary of Merck
                              estradiol) Tablets,    and Co., Inc., 2000
                              0.15 mg/0.03 mg.       Galloping Hill Rd.,
                                                     Kenilworth, NJ
                                                     07033.
NDA 020120.................  AllerNaze              Lupin Atlantis
                              (triamcinolone         Holdings, S.A., c/o
                              acetonide) Nasal       Lupin
                              Spray, 0.05 mg/spray.  Pharmaceuticals,
                                                     Inc., 111 South
                                                     Calvert St.,
                                                     Harborplace Tower,
                                                     24th Floor,
                                                     Baltimore, MD
                                                     21202.
NDA 020628.................  Invirase (saquinavir   Hoffmann-La Roche,
                              mesylate) Capsules,    Inc., 1 DNA Way,
                              equivalent to (EQ)     South San
                              200 mg base.           Francisco, CA,
                                                     94080-4990.

[[Page 47310]]

 
NDA 020937.................  Optimark               Liebel-Flarsheim
                              (gadoversetamide)      Co., LLC., 1034
                              Injection, 330.9 mg/   South Brentwood
                              mL.                    Blvd., Suite 800,
                                                     Richmond Heights,
                                                     MO 63117.
NDA 020947.................  Pennsaid (diclofenac   Nuvo
                              sodium) Topical        Pharmaceuticals,
                              Solution, 1.5%         Inc., c/o Dwayne
                              weight by weight (w/   R.J. Moore, 41
                              w).                    Campus Dr., Suite
                                                     202, New
                                                     Gloucester, ME
                                                     04260.
NDA 020975.................  Optimark               Liebel-Flarsheim
                              (gadoversetamide)      Co., LLC.
                              Injection, 330.9 mg/
                              mL.
NDA 020976.................  Optimark               Do.
                              (gadoversetamide)
                              Injection, 330.9 mg/
                              mL.
NDA 021037.................  Magnevist              Bayer HealthCare
                              (gadopentetate         Pharmaceuticals,
                              dimeglumine)           Inc.
                              Injection, 469.01 mg/
                              mL.
NDA 021105.................  Sulfamethoxazole and   Able Laboratories,
                              Trimethoprim           Inc., 1 Able Dr.,
                              Tablets, 800 mg/160    Cranbury, NJ 08512.
                              mg; and
                              Phenazopyridine HCL
                              Tablets, 200 mg.
NDA 021144.................  Ketek (telithromycin)  Sanofi-Aventis U.S.,
                              Tablets, 300 mg and    LLC., 55 Corporate
                              400 mg.                Dr., Bridgewater,
                                                     NJ 08807.
NDA 021178.................  Glucovance (glyburide  Bristol-Myers Squibb
                              and metformin          Co., P.O. Box 4000,
                              hydrocholoride         Mail Stop: D.2341,
                              (HCl)) Tablets, 1.25   Princeton, NJ 08543-
                              mg/250 mg, 2.5 mg/     4000.
                              500 mg, 5 mg/500 mg.
NDA 021235.................  Prozac Weekly          Eli Lilly and Co.
                              (fluoxetine delayed-
                              release capsules) 90
                              mg.
NDA 021490.................  Femcon Fe (ethinyl     Allergan
                              estradiol and          Pharmaceuticals
                              norethindrone          International
                              tablets, 0.035 mg/     Limited, c/o
                              0.4 mg; and ferrous    Allergan Sales,
                              fumarate tablets, 75   LLC., 5 Giralda
                              mg).                   Farms, Madison, NJ
                                                     07940.
NDA 022011.................  Tyzeka (telbivudine)   Novartis
                              Tablets, 600 mg.       Pharmaceuticals
                                                     Corp.
NDA 022154.................  Tyzeka (telbivudine)   Do.
                              Solution, 100 mg/5
                              mL.
NDA 022328.................  Intermezzo (zolpidem   Purdue
                              tartrate) Sublingual   Pharmaceutical
                              Tablets, 1.75 mg and   Products L.P., 1
                              3.5 mg.                Stamford Forum,
                                                     Stamford, CT 06901-
                                                     3431.
NDA 050456.................  Statrol (neomycin      Alcon Laboratories,
                              sulfate and            Inc., 6201 South
                              polymyxin B sulfate    Freeway, Mail Stop:
                              ophthalmic solution,   TC-45, Fort Worth,
                              USP) EQ 3.5 mg base/   TX 76134-2099.
                              mL; equal to 16,250
                              units polymyxin B/mL.
NDA 204553.................  ColPrep Kit            Gator
                              (magnesium sulfate,    Pharmaceuticals,
                              potassium sulfate,     Inc., 194 Inlet
                              and sodium sulfate)    Dr., Saint
                              for Oral Solution,     Augustine, FL
                              1.6 grams (g)/3.13 g/  32080.
                              17.5 g.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
October 9, 2019. 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 October 9, 2019 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 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19348 Filed 9-6-19; 8:45 am]
 BILLING CODE 4164-01-P