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Determination That BENEMID (Probenecid) Tablet and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA or Agency) has Start Printed Page 81781determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

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Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363,

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In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.

FDA has become aware that the drug products listed in the table in this document are no longer being marketed.

Application No.Drug nameActive ingredient(s)Strength(s)Dosage form/routeApplicant
NDA 007898BENEMIDProbenecid500 milligrams (mg)Tablet; OralMerck and Co., Inc.
NDA 008048XYLOCAINELidocaine5%Ointment; TopicalAstraZeneca Pharmaceuticals LP.
NDA 011111VISTARILHydroxyzine Hydrochloride (HCl)25 mg/milliliter (mL); 50 mg/mLInjectable; InjectionPfizer Inc.
NDA 012209FLUOROURACILFluorouracil500 mg/10 mL (50 mg/mL)Injectable; InjectionSpectrum Pharmaceuticals, Inc.
NDA 013220PERIACTINCyproheptadine HCl2 mg/5 mLSyrup; OralMerck and Co., Inc.
NDA 017534FIORINALAspirin; Butalbital; Caffeine325 mg; 50 mg; 40 mgTablet; OralAllergan Sales, LLC.
NDA 017577DITROPANOxybutynin Chloride5 mgTablet; OralOrtho-McNeil-Janssen Pharmaceuticals, Inc.
NDA 017781DIPROSONEBetamethasone DipropionateEquivalent to (EQ) 0.05% BaseLotion; TopicalSchering Corp.
NDA 018211DITROPANOxybutynin Chloride5 mg/5 mLSyrup; OralOrtho-McNeil-Janssen Pharmaceuticals, Inc.
NDA 018586TOPICORTDesoximetasone0.05%Gel; TopicalTaro Pharmaceuticals U.S.A., Inc.
NDA 018631TRENTALPentoxifylline400 mgExtended-Release Tablet; OralU.S. Pharmaceutical Holdings II, LLC.
NDA 019155LAC-HYDRINAmmonium LactateEQ 12% BaseLotion; TopicalRanbaxy Laboratories Inc.
NDA 019323TEMOVATEClobetasol Propionate0.05%Ointment; TopicalFougera Pharmaceuticals Inc.
NDA 019778PRINZIDEHydrochlorothiazide; Lisinopril12.5 mg/10 mg; 12.5mg/20mgTablet; OralMerck Sharp & Dohme Corp., Subsidiary of Merck & Co., Inc.
NDA 019842MOTRINIbuprofen100 mg/5 mLSuspension; OralMcNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
NDA 019915MONOPRILFosinopril Sodium10 mg; 20 mg; 40 mgTablet; OralBristol-Myers Squibb Co.
NDA 020343PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINERMilrinone LactateEQ 10 mg Base/100 mL; EQ 15 mg Base/100 mL; EQ 20 mg Base/100 mL; EQ 40 mg Base/200 mLInjectable; InjectionSanofi-Aventis U.S. LLC.
NDA 020508LAC-HYDRINAmmonium LactateEQ 12% BaseCream; TopicalRanbaxy Laboratories, Inc.
NDA 020635LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINERLevofloxacinEQ 250 mg/50 mL (EQ 5 mg/mL); EQ 500 mg/100 mL (EQ 5 mg/mL); EQ 750 mg/150 mL (EQ 5 mg/mL)Injectable; InjectionJanssen Pharmaceuticals, Inc.
NDA 020863PLETALCilostazol50 mg; 100 mgTablet; OralOtsuka Pharmaceutical Co., Ltd.
NDA 20950DUONEBAlbuterol Sulfate; Ipratropium BromideEQ 0.083% Base; 0.017%Solution; InhalationMylan Specialty, L.P.
NDA 21460METAGLIPGlipizide; Metformin HCl2.5 mg/250 mg; 2.5 mg/500 mg; 5 mg/500 mgTablet; OralBristol-Myers Squibb Co.
NDA 021759ELOXATINOxaliplatin200 mg/40 mL (5 mg/mL)Injectable; Intravenous (Infusion)Sanofi-Aventis U.S. LLC.
NDA 050442VIBRAMYCINDoxycycline HyclateEQ 100 mg Base/Vial; EQ 200 mg Base/VialInjectable; InjectionPfizer Inc.
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NDA 050624ROCEPHIN W/DEXTROSE IN PLASTIC CONTAINERCeftriaxone SodiumEQ 10 mg Base/mL; EQ 20 mg Base/mL; EQ 40 mg Base/mLInjectable; InjectionHoffmann-La Roche, Inc.
NDA 050739OMNICEFCefdinir300 mgCapsule; OralAbbVie Inc.
NDA 050749OMNICEFCefdinir125 mg/5 mL; 250 mg/5 mLFor Suspension; OralAbbVie Inc.
ANDA 060003V-CILLIN KPenicillin V PotassiumEQ 125 mg Base; EQ 250 mg Base; EQ 500 mg BaseTablet; OralEli Lilly and Company.
ANDA 060463GARAMYCINGentamicin SulfateEQ 0.1% BaseOintment; TopicalSchering-Plough Corp.
ANDA 086833CYPROHEPTADINE HYDROCHLORIDECyproheptadine HCl2 mg/5mLSyrup; OralActavis Mid Atlantic LLC.
ANDA 088877BENZTROPINE MESYLATEBenztropine Mesylate0.5 mgTablet; OralLannett Holdings, Inc.
ANDA 088894BENZTROPINE MESYLATEBenztropine Mesylate1 mgTablet; OralLannett Holdings, Inc.
ANDA 088895BENZTROPINE MESYLATEBenztropine Mesylate2 mgTablet; OralLannett Holdings, Inc.

FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.

Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

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Dated: November 14, 2016.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2016-27855 Filed 11-17-16; 8:45 am]