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Eli Lilly and Co., et al.; Withdrawal of Approval of 25 New Drug Applications

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Food and Drug Administration, HHS.




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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Approval is withdrawn as of October 9, 2019.

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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.

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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 § 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 § 314.150(c) is without prejudice to refiling.

Application No.DrugApplicant
NDA 007529Quinidine Gluconate Injection, 80 milligrams (mg)/milliliters (mL)Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285.
NDA 016096Mintezol (thiabendazole) Chewable Tablet, 500 mgMerck Sharp and Dohme Corp., a subsidiary of Merck and Co., Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889-0100.
NDA 016097Mintezol (thiabendazole) Suspension 500 mg/5 mLDo.
NDA 017439Hydroxyprogesterone Caproate Injection, 125 mg/mL and 250 mg/mLAllergan Sales, LLC., 5 Giralda Farms, Madison, NJ 07940.
NDA 017831Didronel (etidronate disodium) Tablet, 200 mg and 400 mgAllergan Pharmaceuticals International Limited, c/o Allergan Sales, LLC., 2525 Dupont Dr., Irvine, CA 92612.
NDA 019081Estraderm (estradiol transdermal system), 0.05 mg/24 hour (h) and 0.1 mg/24 hNovartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936-1080.
NDA 019596Magnevist (gadopentetate dimeglumine) Injection, 469.01 mg/mLBayer HealthCare Pharmaceuticals, Inc., 100 Bayer Blvd., P.O. Box 915, Whippany, NJ 07981-0915.
NDA 020071Desogen (desogestrel and ethinyl estradiol) Tablets, 0.15 mg/0.03 mgOrganon USA, Inc., a subsidiary of Merck and Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.
NDA 020120AllerNaze (triamcinolone acetonide) Nasal Spray, 0.05 mg/sprayLupin Atlantis Holdings, S.A., c/o Lupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 24th Floor, Baltimore, MD 21202.
NDA 020628Invirase (saquinavir mesylate) Capsules, equivalent to (EQ) 200 mg baseHoffmann-La Roche, Inc., 1 DNA Way, South San Francisco, CA, 94080-4990.
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NDA 020937Optimark (gadoversetamide) Injection, 330.9 mg/mLLiebel-Flarsheim Co., LLC., 1034 South Brentwood Blvd., Suite 800, Richmond Heights, MO 63117.
NDA 020947Pennsaid (diclofenac sodium) Topical Solution, 1.5% weight by weight (w/w)Nuvo Pharmaceuticals, Inc., c/o Dwayne R.J. Moore, 41 Campus Dr., Suite 202, New Gloucester, ME 04260.
NDA 020975Optimark (gadoversetamide) Injection, 330.9 mg/mLLiebel-Flarsheim Co., LLC.
NDA 020976Optimark (gadoversetamide) Injection, 330.9 mg/mLDo.
NDA 021037Magnevist (gadopentetate dimeglumine) Injection, 469.01 mg/mLBayer HealthCare Pharmaceuticals, Inc.
NDA 021105Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg; and Phenazopyridine HCL Tablets, 200 mgAble Laboratories, Inc., 1 Able Dr., Cranbury, NJ 08512.
NDA 021144Ketek (telithromycin) Tablets, 300 mg and 400 mgSanofi-Aventis U.S., LLC., 55 Corporate Dr., Bridgewater, NJ 08807.
NDA 021178Glucovance (glyburide and metformin hydrocholoride (HCl)) Tablets, 1.25 mg/250 mg, 2.5 mg/500 mg, 5 mg/500 mgBristol-Myers Squibb Co., P.O. Box 4000, Mail Stop: D.2341, Princeton, NJ 08543-4000.
NDA 021235Prozac Weekly (fluoxetine delayed-release capsules) 90 mgEli Lilly and Co.
NDA 021490Femcon Fe (ethinyl estradiol and norethindrone tablets, 0.035 mg/0.4 mg; and ferrous fumarate tablets, 75 mg)Allergan Pharmaceuticals International Limited, c/o Allergan Sales, LLC., 5 Giralda Farms, Madison, NJ 07940.
NDA 022011Tyzeka (telbivudine) Tablets, 600 mgNovartis Pharmaceuticals Corp.
NDA 022154Tyzeka (telbivudine) Solution, 100 mg/5 mLDo.
NDA 022328Intermezzo (zolpidem tartrate) Sublingual Tablets, 1.75 mg and 3.5 mgPurdue Pharmaceutical Products L.P., 1 Stamford Forum, Stamford, CT 06901-3431.
NDA 050456Statrol (neomycin sulfate and polymyxin B sulfate ophthalmic solution, USP) EQ 3.5 mg base/mL; equal to 16,250 units polymyxin B/mLAlcon Laboratories, Inc., 6201 South Freeway, Mail Stop: TC-45, Fort Worth, TX 76134-2099.
NDA 204553ColPrep Kit (magnesium sulfate, potassium sulfate, and sodium sulfate) for Oral Solution, 1.6 grams (g)/3.13 g/17.5 gGator Pharmaceuticals, Inc., 194 Inlet Dr., Saint Augustine, FL 32080.

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.

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Dated: September 3, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2019-19348 Filed 9-6-19; 8:45 am]