AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of October 9, 2019.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 § 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. | Drug | Applicant |
|---|---|---|
| NDA 007529 | Quinidine Gluconate Injection, 80 milligrams (mg)/milliliters (mL) | Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285. |
| NDA 016096 | Mintezol (thiabendazole) Chewable Tablet, 500 mg | Merck Sharp and Dohme Corp., a subsidiary of Merck and Co., Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889-0100. |
| NDA 016097 | Mintezol (thiabendazole) Suspension 500 mg/5 mL | Do. |
| NDA 017439 | Hydroxyprogesterone Caproate Injection, 125 mg/mL and 250 mg/mL | Allergan Sales, LLC., 5 Giralda Farms, Madison, NJ 07940. |
| NDA 017831 | Didronel (etidronate disodium) Tablet, 200 mg and 400 mg | Allergan Pharmaceuticals International Limited, c/o Allergan Sales, LLC., 2525 Dupont Dr., Irvine, CA 92612. |
| NDA 019081 | Estraderm (estradiol transdermal system), 0.05 mg/24 hour (h) and 0.1 mg/24 h | Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936-1080. |
| NDA 019596 | Magnevist (gadopentetate dimeglumine) Injection, 469.01 mg/mL | Bayer HealthCare Pharmaceuticals, Inc., 100 Bayer Blvd., P.O. Box 915, Whippany, NJ 07981-0915. |
| NDA 020071 | Desogen (desogestrel and ethinyl estradiol) Tablets, 0.15 mg/0.03 mg | Organon USA, Inc., a subsidiary of Merck and Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033. |
| NDA 020120 | AllerNaze (triamcinolone acetonide) Nasal Spray, 0.05 mg/spray | Lupin Atlantis Holdings, S.A., c/o Lupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 24th Floor, Baltimore, MD 21202. |
| NDA 020628 | Invirase (saquinavir mesylate) Capsules, equivalent to (EQ) 200 mg base | Hoffmann-La Roche, Inc., 1 DNA Way, South San Francisco, CA, 94080-4990. |
| NDA 020937 | Optimark (gadoversetamide) Injection, 330.9 mg/mL | Liebel-Flarsheim Co., LLC., 1034 South Brentwood Blvd., Suite 800, Richmond Heights, MO 63117. |
| NDA 020947 | Pennsaid (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 020975 | Optimark (gadoversetamide) Injection, 330.9 mg/mL | Liebel-Flarsheim Co., LLC. |
| NDA 020976 | Optimark (gadoversetamide) Injection, 330.9 mg/mL | Do. |
| NDA 021037 | Magnevist (gadopentetate dimeglumine) Injection, 469.01 mg/mL | Bayer HealthCare Pharmaceuticals, Inc. |
| NDA 021105 | Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg; and Phenazopyridine HCL Tablets, 200 mg | Able Laboratories, Inc., 1 Able Dr., Cranbury, NJ 08512. |
| NDA 021144 | Ketek (telithromycin) Tablets, 300 mg and 400 mg | Sanofi-Aventis U.S., LLC., 55 Corporate Dr., Bridgewater, NJ 08807. |
| NDA 021178 | Glucovance (glyburide and metformin hydrocholoride (HCl)) Tablets, 1.25 mg/250 mg, 2.5 mg/500 mg, 5 mg/500 mg | Bristol-Myers Squibb Co., P.O. Box 4000, Mail Stop: D.2341, Princeton, NJ 08543-4000. |
| NDA 021235 | Prozac Weekly (fluoxetine delayed-release capsules) 90 mg | Eli Lilly and Co. |
| NDA 021490 | Femcon 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 022011 | Tyzeka (telbivudine) Tablets, 600 mg | Novartis Pharmaceuticals Corp. |
| NDA 022154 | Tyzeka (telbivudine) Solution, 100 mg/5 mL | Do. |
| NDA 022328 | Intermezzo (zolpidem tartrate) Sublingual Tablets, 1.75 mg and 3.5 mg | Purdue Pharmaceutical Products L.P., 1 Stamford Forum, Stamford, CT 06901-3431. |
| NDA 050456 | Statrol (neomycin sulfate and polymyxin B sulfate ophthalmic solution, USP) EQ 3.5 mg base/mL; equal to 16,250 units polymyxin B/mL | Alcon Laboratories, Inc., 6201 South Freeway, Mail Stop: TC-45, Fort Worth, TX 76134-2099. |
| NDA 204553 | ColPrep Kit (magnesium sulfate, potassium sulfate, and sodium sulfate) for Oral Solution, 1.6 grams (g)/3.13 g/17.5 g | Gator 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.
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