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INVANZ® (Ertapenem Sodium)

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INVANZ® (Ertapenem Sodium) CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: NDA 21-337/S-021 Trade Name: INVANZ® Generic Name: Ertapenem sodium Sponsor: Merck & Co., Inc. Approval Date: August 10, 2006 Indications: for the prophylaxis of surgical site infection following elective colorectal surgery CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: NDA 21-337/S-021 CONTENTS Reviews / Information Included in this NDA Review. Approval Letter X Other Action Letters Labeling X REMS Summary Review Officer/Employee List Office Director Memo Cross Discipline Team Leader Review Medical Review(s) X Chemistry Review(s) Environmental Assessment Pharmacology Review(s) Statistical Review(s) X Microbiology Review(s) X Clinical Pharmacology/Biopharmaceutics Review(s) X Other Reviews X Risk Assessment and Risk Mitigation Review(s) Proprietary Name Review(s) Administrative/Correspondence Document(s) X CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: NDA 21-337/S-021 APPROVAL LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 21-337/S-021 Merck & Co., Inc. Attention: Jeffrey R. Tucker, MD Director, Regulatory Affairs Sumneytown Pike P.O. Box 4, BLA-20 West Point, PA 19486 Dear Dr. Tucker: Please refer to your supplemental new drug application dated November 9, 2005, received November 10, 2005 submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for INVANZ® (Ertapenem Sodium). We acknowledge receipt of your submissions dated January 20, February 13, February 17, March 20, March 23, April 6, April 18, April 27, May 11 (2), June 1, June 19, and June 23, 2006. This supplemental new drug application provides for the use of INVANZ® (Ertapenem Sodium) for the prophylaxis of surgical site infection following elective colorectal surgery. We have completed our review of this application, as amended. This application is approved, effective on the date of this letter, for use as recommended in the agreed-upon labeling text. Submit content of labeling [21 CFR 314.50(1)] in structured product labeling (SPL) format, as described at http://www.fda.gov/oc/datacouncil/spl.html, that is identical to the enclosed labeling text. Upon receipt and verification, we will transmit that version to the National Library of Medicine for posting on the DailyMed website. Please submit an electronic version of the FPL according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format - NDA. Alternatively, you may submit 20 paper copies of the FPL as soon as it is available but no more than 30 days after it is printed. Individually mount 15 of the copies on heavy-weight paper or similar material. For administrative purposes, designate this submission "FPL for approved supplement NDA 21-337/S-021”. Approval of this submission by FDA is not required before the labeling is used. All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We are waiving the pediatric study requirement for this application. In addition, submit three copies of the introductory promotional materials that you propose to use for this product. Submit all proposed materials in draft or mock-up form, not final print. Send one copy to this division and two copies of both the promotional materials and the package inserts directly to: NDA 21-337/S-021 Page 2 Food and Drug Administration Center for Drug Evaluation and Research Division of Drug Marketing, Advertising, and Communications 5901-B Ammendale Road Beltsville, MD 20705-1266 If you issue a letter communicating important information about this drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to the following address: MEDWATCH Food and Drug Administration WO 22, Room 4447 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81). If you have any questions, call Susmita Samanta, MD, Regulatory Project Manager, at (301) 796-1400. Sincerely, {See appended electronic signature page} Janice M. Soreth, M.D. Director Division of Anti-Infective and Ophthalmology Products Office of Antimicrobial Products Center for Drug Evaluation and Research Enclosure --------------------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------------------- /s/ --------------------- Janice Soreth 8/10/2006 02:04:53 PM CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: NDA 21-337/S-021 LABELING NDA 21-337/S-021 Page 3 ® INVANZ (ERTAPENEM FOR INJECTION) To reduce the development of drug-resistant bacteria and maintain the effectiveness of INVANZ and other antibacterial drugs, INVANZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. For Intravenous or Intramuscular Use DESCRIPTION INVANZ∗ (Ertapenem for Injection) is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics. Chemically, INVANZ is described as [4R-[3(3S*,5S*),4α,5β,6β(R*)]]-3-[[5-[[(3- carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1- azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt. Its molecular weight is 497.50. The empirical formula is C22H24N3O7SNa, and its structural formula is: OH _ CH3 H H COO H3C S N Na+ O _ COO NH + N H 2 O Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol, and insoluble in isopropyl acetate and tetrahydrofuran. INVANZ is supplied as sterile lyophilized powder for intravenous infusion after reconstitution with appropriate diluent (see DOSAGE AND ADMINISTRATION, PREPARATION OF SOLUTION) and transfer to 50 mL 0.9% Sodium Chloride Injection or for intramuscular injection following reconstitution with 1% lidocaine hydrochloride. Each vial contains 1.046 grams ertapenem sodium, equivalent to 1 gram ertapenem. The sodium content is approximately 137 mg (approximately 6.0 mEq). Each vial of INVANZ contains the following inactive ingredients: 175 mg sodium bicarbonate and sodium hydroxide to adjust pH to 7.5. CLINICAL PHARMACOLOGY Pharmacokinetics Average plasma concentrations (mcg/mL) of ertapenem following a single 30-minute infusion of a 1 g intravenous (IV) dose and administration of a single 1 g intramuscular (IM) dose in healthy young adults are presented in Table 1. ∗ Registered trademark of MERCK & CO., Inc. COPYRIGHT © 2001, 2003, 2004, 2005 MERCK & CO., Inc. All rights reserved NDA 21-337/S-021 Page 4 Table 1 Plasma Concentrations of Ertapenem in Adults After Single Dose Administration Average Plasma Concentrations (mcg/mL) Dose/Ro 0.5 1 hr 2 hr 4 hr 6 hr 8 hr 12 hr 18 hr 24 hr ute hr 1 g IV* 155 115 83 48 31 20 9 3 1 1 g IM 33 53 67 57 40 27 13 4 2 *Infused at a constant rate over 30 minutes The area under the plasma concentration-time curve (AUC) of ertapenem in adults increased less-than dose-proportional based on total ertapenem concentrations over the 0.5 to 2 g dose range, whereas the AUC increased greater-than dose proportional based on unbound ertapenem concentrations. Ertapenem exhibits non-linear pharmacokinetics due to concentration-dependent plasma protein binding at the proposed therapeutic dose. (See CLINICAL PHARMACOLOGY, Distribution.) There is no accumulation of ertapenem following multiple IV or IM 1 g daily doses in healthy adults. Average plasma concentrations (mcg/mL) of ertapenem in pediatric patients are presented in Table 2. Table 2 Plasma Concentrations of Ertapenem in Pediatric Patients After Single IV* Dose Administration Age Group Dose Average Plasma Concentrations (mcg/mL) 0.5 hr 1 hr 2 hr 4 hr 6 hr 8 hr 12 hr 24 hr 3 to 23 months 15 103.8 57.3 43.6 23.7 13.5 8.2 2.5 - mg/kg† 126.8 87.6 58.7 28.4 - 12.0 3.4 0.4 20 199.1 144.1 95.7 58.0 - 20.2 7.7 0.6 mg/kg† 40 mg/kg‡ 2 to 12 years 15 113.2 63.9 42.1 21.9 12.8 7.6 3.0 - mg/kg† 147.6 97.6 63.2 34.5 - 12.3 4.9 0.5 20 241.7 152.7 96.3 55.6 - 18.8 7.2 0.6 mg/kg† 40 mg/kg‡ 13 to 17 years 20 170.4 98.3 67.8 40.4 - 16.0 7.0 1.1 mg/kg† 155.9 110.9 74.8 - 24.0 - 6.2 - 1 g§ 255.0 188.7 127.9 76.2 - 31.0 15.3 2.1 40 mg/kg‡ * Infused at a constant rate over 30 minutes † up to a maximum dose of 1 g/day ‡ up to a maximum dose of 2 g/day § Based on three patients receiving 1 g ertapenem who volunteered for pharmacokinetic assessment in one of the two safety and efficacy studies Absorption Ertapenem, reconstituted with 1% lidocaine HCl injection, USP (in saline without epinephrine), is almost completely absorbed following intramuscular (IM) administration at the recommended dose of 1 g. The mean bioavailability is approximately 90%. Following 1 g daily IM administration, mean peak plasma concentrations (Cmax) are achieved in approximately 2.3 hours (Tmax). Distribution Ertapenem is highly bound to human plasma proteins, primarily albumin. In healthy young adults, the protein binding of ertapenem decreases as plasma concentrations increase, from approximately NDA 21-337/S-021 Page 5 95% bound at an approximate plasma concentration of <100 micrograms (mcg)/mL to approximately 85% bound at an approximate plasma concentration of 300 mcg/mL.
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