EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE GLAXOSMITHKLINE 21-078 SE5 006 2-Jun-03 2-Dec-03 Y 6.0 Provides for the use of Malarone (atovaquone and proguanil hydrochloride) Pediatric Tablets, 62.5 mg/25 mg for the treatment of Plasmodium falciparum malaria in pediatric patients weighing 5 kg to 11 kg
C:\Documents and Settings\ROCAR\Desktop\Contents of D Drive\Malaron\ e\ped_clin_summary.doc Box 7929 Philadelphia, Pennsylvania 19101 Drug names Chemical: (atovaquone) trans- 2-[ 4-( 4- chlorophenyl) cyclohexyl]- 3- hydroxy1,4- napthoquinone (proguanil) 1-( 4- chlorophenyl)- 5- isopropyl biguanide hydrochloride Established: Atovaquone and Proguanil Hydrochloride tablets Proprietary: Malarone® Route Oral Formulations Malarone® pediatric...
author: Renata Albrecht
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FDA Drug Approvals List July 2000 - Drug Approvals for July 2000 Definitions and Notes Original New Drug Applications Original Application #: 050779 Approval Date: 27-JUL-00 Trade Name: CEFAZOLIN AND DEXTROSE Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: B BRAUN MEDICAL INC Active Ingredient(s): CEFAZOLIN SODIUM OTC/RX Status: RX Indication(s): For the treatment of respiratory tract...
FDA Drug Approvals List- June 1999 Drug Approvals for June 1999 Definitions and Notes June 1999 Original New Drug Applications Original Application #: 020968 Approval Date: 30-JUN-99 Trade Name: MONISTAT DUAL PAK Chemical Type: 3 Therapeutic Potential: S Dosage Form: SUPPOSITORY Applicant: ADVANCED CARE PRODUCTS Active Ingredient(s): MICONAZOLE NITRATE OTC/RX Status: RX Indication(s): TREATMENT OF VULVOVAGINAL...
Malaria: Parasitic Infections: Merck Manual Home Edition Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
Pediatric Exclusivity Labeling Changes Food and Drug Administration • Center for Drug Evaluation and Research Pediatrics Search Pediatric Exclusivity Labeling Changes as of February 6, 2004 - - Exclusivity Granted (Labeled) Product Indications Label Changes 1Atovaquone / Proguanil -- Malarone (Glaxo) Pediatric Formulation Prophylaxis and...
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies Food and Drug Administration • Center for Drug Evaluation and Research Pediatrics Search Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies as of January 28, 2004 Summaries of Medical and Clinical Pharmacology Reviews Drug Sponsor Review Summary Alendronate - Fosamax Merck Medical Clinical Pharmacology Atovaquone and Proguanil - Malarone ...
author: CDER Office of New Drugs
DOCUMENT INFORMATION PAGE Dosage for Prevention of Malaria in Pediatric Patients 386 Weight (kg) Atovaquone/ Proguanil HCl Total Daily Dose Dosage Regimen 11- 20 62.5 mg/ 25 mg 1 MALARONE Pediatric Tablet daily 21- 30 125 mg/ 50 mg 2 MALARONE Pediatric Tablets as a single dose daily 31- 40 187.5 mg/ 75 mg 3 MALARONE Pediatric Tablets as a single dose daily >40 250 mg/ 100 mg 1 ...
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News Along the Pike, July 2000 Food and Drug Administration • Center for Drug Evaluation and Research About CDER - Search CDER News Along the Pike July 2000 Issue 7 Center for Drug Evaluation and Research PDF version for printoutsMalarone Team: Funmilayo O
author: Oliver
http://www.fda.gov/cder/foi/label/2002/21078s3lbl.pdf Dosage for Prevention of Malaria in Pediatric Patients Weight (kg) Atovaquone/ Proguanil HCl Total Daily Dose Dosage Regimen 11- 20 62.5 mg/ 25 mg 1 MALARONE Pediatric Tablet daily 21- 30 125 mg/ 50 mg 2 MALARONE Pediatric Tablets as a single dose daily 31- 40 187.5 mg/ 75 mg 3 MALARONE Pediatric Tablets as a single dose daily >40 250 mg/ 100 mg 1 ...
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