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 1Pimecrolimus - Elidel (Novartis) Label [PDF ] Treatment of mild/moderate atopic dermatitis Indicated for short-term and...
http://www.fda.gov/cder/orange/appendix_a.txt 400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE ECONOCHLOR, CHLORAMPHENICOL ECONOPRED PLUS, PREDNISOLONE ACETATE ECONOPRED, PREDNISOLONE ACETATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDETATE DISODIUM, EDETATE DISODIUM EDEX, ALPROSTADIL EDROPHONIUM CHLORIDE PRESERVATIVE FREE, EDROPHONIUM...
21-302_ELIDEL Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Elidel (Pimecrolimus) Cream Company:--Novartis Pharmaceuticals Corporation Application No.:--21-302 Approval Date:-12/13/2001 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Part 1 - Part 2 - Part 3 - Chemistry Review(s) - Environmental Assessment -...
author: Paul Stauffer
CDER Report to the Nation: 2001 New molecular entities Almotriptan malate (Axert) Bimatoprost (Lumigan) Bosentan (Tracleer) Caspofungin acetate (Cancidas) Cefditoren pivoxil (Spectracef) Desloratadine (Clarinex) Drospirenone/ethinyl estradiol (Yasmin) Dutasteride (Dutasteride) Ertapenem sodium (Invanz) Etonogestrel/ethinyl estradiol (NuvaRing) Fondaparinux sodium (Arixtra) Formoterol fumarate (Foradil Aerolizer)...
author: OLIVERN
Microsoft Word - n21302s04apLT.doc The structural formula is Pimecrolimus is a white to off- white fine crystalline powderPimecrolimus was administered during the period of organogenesis (2 weeks prior to mating until gestational day 16 in rats, gestational days 6- 18 in rabbits) up to dose levels of 45 mg/ kg/ day in rats and 20 mg/ kg/ day in rabbitsPimecrolimus was administered from...
author: PAPPAS
Microsoft Word - n21302s04apLT.doc page 3
author: PAPPAS
Microsoft Word - n21302s04apLT.doc page 1
author: PAPPAS
NDA Approvals for Calendar Year 2001 Braun 5 S 21-Feb-01 21-235 Prozac Weekly Fluoxetine Hydrochloride Eli Lilly 3 S 26-Feb-01 21-169 Reminyl Galantamine Hydrobromide Janssen Research 1 S 28-Feb-01 21-082 Tavist Allergy/Sinus/Headache Acetaminophen/Clemastine Fumarate/Pseudoephedrine Hydrochloride Novartis 4 S 01-Mar-01 21-257 Travatan Travoprost Alcon 1 P 16-Mar-01 21-262 Alphagan P Brimonidine Tartrate Allergan 3 S 16...
author: Brenda Harmon
Prescription and OTC Drug Product List 12/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL SYNALGOS-DC-A -A- @ WOMEN FIRST HLTHCARE 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN -D- @ WYETH AYERST 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL ANEXSIA 5/325 -D- AA MALLINCKRODT 325MG;5MG N40409...
C:\WINDOWS\DESKTOP\N21302_APltr.doc The structural formula is: O O O OH O N O O O O OH O Cl H H Pimecrolimus is a white to off- white fine crystalline powderPimecrolimus was administered during the period of organogenesis (2 weeks prior to mating until gestational day 16 in rats, gestational days 6- 18 in rabbits) up to dose levels of 45 mg/ kg/ day in rats and 20 mg/ kg/ day in rabbits
author: Mildred Wright
C:\WINDOWS\DESKTOP\N21302_APltr.doc page 8
author: Mildred Wright
duplicates:http://www.fda.gov/cder/foi/label/2001/21302lbl.pdf
C:\WINDOWS\DESKTOP\N21302_APltr.doc page 1
author: Mildred Wright
duplicates:http://www.fda.gov/cder/foi/label/2001/21302lbl.pdf
C:\WINDOWS\DESKTOP\N21302_APltr.doc The structural formula is: O O O OH O N O O O O OH O Cl H H Pimecrolimus is a white to off- white fine crystalline powderPimecrolimus was administered during the period of organogenesis (2 weeks prior to mating until gestational day 16 in rats, gestational days 6- 18 in rabbits) up to dose levels of 45 mg/ kg/ day in rats and 20 mg/ kg/ day in rabbits
author: Mildred Wright
Progress: Product Labeling with Significant Changes for Dosing or Risk Progress: Product Labeling with Significant Changes for Dosing or Risk Ribavirin/Intron A (Rebetron): increased incidence of suicidal ideation or attempts among pediatric patients as compared with adults (2.4% vsPimecrolimus (Elidel) - indicated for...
Children in Research Children in Research Pimecrolimus (Elidel) - indicated for short-term and intermittent long-term therapy in mild-moderate atopic dermatitis in non-immunocompromised patients -2 years of age; (NOT RECOMMENDED in patients -2 years of age for safety concerns including infections, pyrexia, and diarrhea) Previous slide Next slide Back to first slide View graphic version...
The Federal Government: Recent changes at FDA and the Implications for Pediatric Clinical Trials Children in Research Pimecrolimus (Elidel) - indicated for short-term and intermittent long-term therapy in mild-moderate atopic dermatitis in non-immunocompromised patients >2years of age; (NOT RECOMMENDED in patients <2 years of age for safety concerns including infections, pyrexia, and diarrhea) Overview Historical Perspective Benchmarks Results of Legislation Health...
author: FDA.CDER
Product Labeling with Significant Changes for Dosing or Risk (continued) Product Labeling with Significant Changes for Dosing or Risk (continued) Bethamethasone (Diprosone, Diprolene, Lotrisone)- HPA (adrenal suppression) as determined by cosyntropin tests Diprosone and Diprolene - local AEs (e.g., skin atrophy) seen and not recommended -12 years of age; Lotrisone - not recommended -17 years of age Pimecrolimus (Elidel) - indicated for short...
Progress: Product Labeling with Significant Changes for Dosing or Risk Progress: Product Labeling with Significant Changes for Dosing or Risk Ribavirin/Intron A (Rebetron): increased incidence of suicidal ideation or attempts among pediatric patients as compared with adults (2.4% vsPimecrolimus (Elidel) - indicated for...
BioPortfolio Limited 70 Novartis – partner, or acquisition, needed 70 Altana – key late-stage player 71 Schering-Plough – hurt by delays and shallow pipeline 71 SWOT methodology 72 CHAPTER 5 PDE-4 LATE-STAGE DRUG ANALYSIS & FORECASTS 76 PDE-4 inhibitor pipeline summary 77 Daxas (roflumilast) 78 Profile 78 Forecasts to 2014 83 Ariflo (cilomilast) 85 Profile 85 Forecasts to 2014 92...
Approved Active Moieties to Which FDA has Granted Pediatric Exclusivity for Pediatric Studies Approved Active Moieties to Which FDA has Granted Pediatric Exclusivity for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act NOTE: This list simply identifies approved active moieties with sponsors to which FDA has granted exclusivity for pediatric studies
http://www.adis.com/files/newsletters/PT/PTcov62.pdf 9 Therapy Pneumococcal conjugate vaccine not linked to Basiliximab without corticosteroids for transplants 5 asthma 9 Corticosteroid- free liver transplantation in children 5 Risperidone: transient increase in prolactin levels in Imatinib for residual disease in paediatric Ph+ CML 6 children 9 Levosalbutamol helps paediatric ED patients breathe SSRIs: Task Force disputes link with...
http://www.adis.com/files/newsletters/REA/Rxcov985.pdf 5 Paclitaxel: necrotising enterocolitis [S] 14 Olanzapine associated with increased insulin resistance 5 Paroxetine: interaction with concomitant olanzapine leading to 14 Paroxetine: increased LDL- cholesterol in healthy volunteers 5 neuroleptic malignant syndrome [ X S] Vigabatrin- associated retinal dysfunction 4 Petrolatum: lipoid pneumonia [ ] 14 Phenytoin: linear IgA bullous...
http://www.adis.com/files/newsletters/REA/Rxcov986.pdf 3 Paroxetine: interaction with concomitant ziprasidone leading 14 Risperidone: transient increase in prolactin levels in children 4 to mania [ X] Snake antivenin: ARs reduced with chlorphenamine + 5 Penicillamine: epidermolysis bullosa 12 hydrocortisone Pimecrolimus: eczema herpeticum [ S] 12 Tamoxifen use increases risk of malignant mixed mullerian 3 Piperacillin/ tazobactam/...
Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal 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 moieties to which FDA has issued a Written Request for pediatric studies since June 1998
PII: S0140-6736(03)12193-9 For personal use.
