DEPARTMENT OF HEALTH &t HUMAN SERVICES .

Food and Drug Administretion Rockville MD 20857

JUN4

71103

Michele R. Flicker, MD, PhD, FACP Director, Regulatory Affairs Merck & Co., Inc. P.O. Box 2000 Rahway, NJ 07065 Re: Docket Nos. 02P-0363KPl and 99P-2547KPl Dear Dr. Flicker: This respondsto your letter dated May 22, 2003, regarding Fosamax(alendronatesodium) tablets. In your letter, you request that FDA remove from docket numbers 02P-0363/CPl and 99P-2547KPl the October 27, 2000, written request to Merck for studies of alendronate in pediatric patients with osteogenesis imperfecta and the March 8, 2002, amendmentto the written request. You also state that Merck considers the contents of the written request and the amendmentto be confidential and not subject to public disclosure under the Freedom of Information Act (FOIA) without the written permission of Merck. The Agency generally considers written requestsfor pediatric studies to be confidential under the FOIA until the studies conducted pursuant to the written request are completed and the product is approved for a pediatric use based on the studies. The October 27, 2000, written request and March 8, 2002, amendmentwere originally placed in the public docket in response to your citizen petition dated August 12, 2002 (Docket No. 02P-0363/CPl, the Petition). In the Petition, you stated that you wanted the written request referenced in the public docket to reflect the Agency’ position regarding the appropriatenessand safety of the study of s alendronate sodium in the pediatric population. The Agency has removed the October 27, 2000, written request and the March 8, 2002, amendmentfrom docket numbers 02P-0363/CPl and 99P-2547KPl. To clarify FDA’ s current position regarding the study of alendronatesodium in the pediatric population, we have replaced the written request and amendmentwith the publicly available list of Approved Active Moieties to which FDA has issued a Written Requestfor Pediatric Studiesunder Section 505A of the Federal Food, Drag, and CosmeticAct. Pleaselet me know if you have any further concerns about this matter. Sincerely yours, ,

Jan&&odcock, M.D. Director Center for Drug Evaluation and Research Enclosure

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Approved Active Moieties to which FDA has issueda Written Requestfor Pediatric Studio... Page 1 of 8

Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act
NOTE: This list simply identifies approved active moietiesto which FDA has issued a Written Request for pediatric studiessince June 1998.If a product appears this list, it does not imply that studies have on been conductedor submitted to the Agency, nor doesit meanthat the studies described in the Written Requestwill be conducted.A sponsor is NOT requiredto perform pediatric studies in responseto a Written Request.Conducting pediatric studies in response a Written Request is voluntary. For a list of to approvedproducts containing the active moiety by the sponsorpleasesee “CDER New and Genetic Drug ApproX3!s”(h_~l~~wwl?L,fda.g~~~~~~~/~p~r~~~i~. Total Approved Active Moieties Issued a Written Request = 222
Adive Moiety
sponsor

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Abacavir Acetazolamide Albuterol Albuterol Alendronate Almotriptan Alosetron Amiodarone Amlexanox Amlodipine Amlodipine/Benazepril Ammonium Lactate Amprenavir Anagrelide HCL Anastrozole Argatroban Injection Aripiprazole
Atorvastatin

Glaxo Wellcome, Inc. Wyeth-Ayerst . Dey 1 GlaxoSmithKline Merck Pharmacia& Upjohn Glaxo Wellcome, Inc. Wyeth Ayers-t Block Drug IPfizer, Inc. ‘ Novartis Westwood Squibb IGlaxo Wellcome, Inc. ShiR Astra Zeneca Texas Biotechnology lotsuka 1 Warner-Lambert Glaxo Wellcome, Inc. ASTA Medica Salix Pharm. 7

Atovaquone/Proguanil Azelastine rBalsalazide

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5/27/2003

htt.p://www.fda.gov/cder/pediatric/wrlist.htm

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Approved,Active Moieties to which FDA has issued a Written Request for Pediatric Studit... Page 2 of 8

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Beclomethasone Benazepril Betamethasone Betaxolol
Betaxolol

] ISchering 1[Schering 1 Lorex Pharmaceuticals I Alcon 1 AstraZenencaPharm. 1 Wyeth-Ayerst pllergan, Inc. IAlcon 1(Astra Zeneca ’ j IGlaxo Wellcome. Inc 1IBristol-Mvers Sauibb 1jOrohan Medical t IAbbott * 1lAstra Pharmaceuticals Bristol-Myers Squibb CIBA 1k3nithKhe Beecham 1 Merck 1 I I I I I I

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Bicalutamide Bisoprolol Brimonidine Brinzolamide Budesonide Buorobrion Busnirone Busulfan Calcitriol Candesartan Carboplatin , Carte0101 karvedilol Caspofungin Celecoxib herivastatin ketirizine Cilostazol Cimetidine Ciprofloxacin Ciprofloxacin Cisatracurium @alopram (Clopidogrel Bisulfate IColesevelamHydrochloride rCromolyn Sodium Cromolyn Sodium

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I Searle I IBaver
I hizer 1 Otsuka 1 SmithKline Beecham 1IBayer 1IAlcon 1IGlaxo Wellcome 1IForestLaboratories, Inc. Sanofi-Synthelabo sankyoPhalma IPharmaciaBi Upjohn 1IBausch8c Lomb II

http://www.fda.gov/cder/pediatric/wrlist.htm

5/27/2003

Approved Active Moieties to which FDA has issued a Written Requestfor Pediatric Studio... Page 3 of .8

Cytarabine
Desflurane

SkyePhannaInc. Baxter Healthcare Merck Bristol-Myers Squibb Merck DuPont Pharmaceuticals Merck offman-La Roche Aventis Pharmacia& Upjohn IMerck Baxter Pharmaceutical AstraZeneca Wyeth-Ayerst Novartis Merck Astra Pharmaceuticals Elan Pharmaceuticals JanssenPharmaceutics Aventis Pfizer Berlex Lilly Glaxo Wellcome, Inc. Novartis Solvay Pharmaceuticals Novartis 1 Bristol-Myers Squibb Pfizer IAstraZenecaPharmaceut Parke-Davis Bristol-Myers Squibb I I

Dichlorphenamide Didanosine Dorzolamide Efavirenz Enalapril Maleate Enfuvirtide Enoxaparin Epirubicin Ertapenem Esmolol Esomeprazole Etodolac Famciclovir Famotidine Felodipine Fenoldopam Fentanyl Fexofenadine Fluconazole Fludarabine Fluoxetine Fluticasone Fluvastatin Fluvoxamine Formoterol fumarate Fosinopril Fosphenytoin Fulvestrant Gabapentin Gatifloxacin I

http://www.fda.gov/cderlpediatric/wrlist.htm

S/27/2003

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Approved,Active Moieties to which FDA has issueda Written Requestfor Pediatric Studic... Page 5 of 8

Linezolid Lisinopril Lisinopril Lopinavir/Ritonavir Loratadine Losartan Lovastatin ,Mesalamine IMetformin
,

Pharmacia& UpJohn ZenecaPharmaceuticals Merck 1IAbbott 1 Schering 1 Merck 1/Merck 1IProcter8c Gamble 1(Bristol-Mvers Sauibb 1IWveth-Averst Bausch & Lomb Astra Zeneca

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IMethazolamide Metipranolol Metobrolol [Midazolam Milrinone Minoxidil Mirtazapine Moexinril IMometasone IMontelukast [Morphine Morphine Nabumetone Nateglinide Nefazodone Nelfmavir Nevirapine Nicotine Nizatidine Norfloxacin lNorgestimate/ethinyl estradiol Ofloxacin [Olanzapine .

I (Hoffmann-La Roche
Sanofl Synthelabo,Inc. Pharmacia& UpJobn Organon Inc. 1 Schwarz Pbarma

I IScherinsr I IMerck & Co.. Inc.
Elan Drug Delivery Faulding SmithKline Beecham Novartis Bristol-Myers Squibb Agouron Pharmaceutical Boehringer Ingelheim SmithKline Beecham 1/Reliant I IMerck R.W. Johnson Allergan I ILilly

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http://www.fda.gov/cder/pediatriclwrlist.htm

S/27/2003

Approved Active Moieties to which FDA has issued a Written Requestfor Pediatric Studic... Page 6 of 8 . Dmeprazole Ondansetron Ddistat Dseltamivir Dxaprozin Oxcarbazepine Oxybutynin Oxycodone Pantoprazole Paricalcitol Paroxetine Pemirolast Pimecrolimus ‘ Pioglitazone IPolyethelene Glycol IPravastatin /Pronofol /OuetianineFumerate
lOUillilKd

] ~Aslraikneca 1IGlaxo Wellcome 1IHoffman-LaRoche 1IRoche 1ISearle ovartis 1 PurduePharmaL.P. Wyeth-Ayerst Abbott SmithKline Beecham Santen Novartis Takeda Braintree Labs 1 Bristol-Myers Squibb I IZenecaPharmaceuticals 1lAstraZeneca 1IParke-Davis 1IEisai, Inc. Ring Pharm. GlaxoWellcome, Inc. Glaxo Wellcome. Inc. 1/Nova Nordisk

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IRabeprazole RiUllipd Ranitidine Remifentanil henaelinide

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IRibavirin in combination with Interferon I ISchering alfa-2B, recombinant II IRifapentine Risedronate Risperidone Ritonavir Rocuronium Rofecoxib III Hoechst-Marion Roussel Procter & Gamble Janssen Research Abbott Laboratories Organon Merck

http://www.fda.gov/cder/pediatriclwrlist.htm

S/27/2003

Approved Active Moieties to which FDA has issueda Written Requestfor Pediatric Studic... Page 7 of 8

iopivacaine Xosiglitazone jalmeteroi
3aauinavir

Astra Zeneca 1 SmithKline Beecham 1 Glaxo Wellcome. Inc. 1IHofEnan-La Roche Inc. Pfizer Pharmaceuticals GelTex Abbott Knoll Pharmaceutical Pfizer 1IMerck 1IWveth-Averst IWatsonLaboratories SeronoLaboratories Berlex Laboratories, Inc.
I [Bristol-Mvers Sauibb

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Sertraline Sevelamer Sevoflurane Sibutramine Sildenafil Simvastatin Sirolimus Sodium ferric gluconate complex Somatropin [rDNA origin]
Stavuclme
SllmatriDtan

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1IGlaxo Wellcome. Inc. IAstra Zeneca Schering Gilead Sciences Novartis IUnimed Pharmaceuticals /Merck j IFalcon Pharmaceuticals 1lSanten IFalcon Pharmaceuticals IPharmacia& Upjohn 1~SmithIUineBeecham
R.W. Johnson

Tamoxifen Temozolomide Tenofovir Terbinafine ‘ Testosterone
ITimolol ITimolol lTimolo1

Tobramycin Tolterodine
lTo~otecan Tramadol Vdacvclovir

GlaxoSmithKline IRoche IAbbott Laboratories 1INovartis Pharmaceuticals
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Valganciclovir Valproate Valsartan
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http://www.fda.gov/cder/pediatricfwrlist.htm

5/27/2003

Approved &tive Moieties to which FDA has issueda Written Request for Pediatric St&... . Venlafaxine Verapamil Vinorelbine IVoriconazole IZafirlukast kanamivir kimasidone koledronic acid Zolmitriptan Zonisamide 1IWyeth-Aye& Elan Pharmaceuticals Glaxo Wellcome I IPfizer 1IZenecaPharmaceuticals 1(Glaxo Wellcome. Inc I IPfizer 1I~ovartis Pharmaceuticals 1IZenecaPharmaceuticals 1IElan Pharmaceuticals I I I I

Page 8 of 8

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Last Updated: May 8,2003

http://www.fda.gov/cder/pediatric/wriist.htm

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