FDA labeling changes(Total Drugs:10) |
|---|
| DiseaseID |
Pediatric_Labeling_Date |
Trade_Name |
Generic_Name_or_Proper_Name |
Indications Studied |
Label Changes Summary |
Product Labeling |
BPCA(B) |
PREA(P) |
BPCA(B) and PREA(P) |
Pediatric Rule (R) |
Sponsor |
Pediatric Exclusivity Granted Date |
NNPS |
| MESH:D002547 | 12/22/2009 | topamax | topiramate | Migraine Prophylaxis | Safety and effectiveness for migraine prevention in pediatric patients have not been established Dose-related increased shift in serum creatinine in adolescent patients occurred in a clinical study Information added to Warnings and Precautions and Pediatric Use | Labeling | - | P | - | - | Ortho-McNeil-Janssen | - | FALSE' |
| MESH:D002547 | 12/22/2009 | topamax | topiramate | Migraine Prophylaxis | Safety and effectiveness for migraine prevention in pediatric patients have not been established Dose-related increased shift in serum creatinine in adolescent patients occurred in a clinical study Information added to Warnings and Precautions and Pediatric Use | Labeling | - | P | - | - | Ortho-McNeil-Janssen | - | FALSE' |
| MESH:D002547 | 12/22/2009 | topamax | topiramate | Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months | Effectiveness was not demonstrated as adjunctive therapy in a randomized, double-blind trial in infants/toddlers 1 to 24 months of age with refractory partial onset seizures Trials in infants/toddlers 1 to 24 months suggested some adverse reactions/toxicities not previously observed in older pediatric patients and adults; i.e, growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. Information added to Warnings and Precautions and Pediatric Use | Labeling | B | - | - | - | Ortho-McNeil-Janssen | 07/24/2008 | FALSE' |
| MESH:D002547 | 12/22/2009 | topamax | topiramate | Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months | Effectiveness was not demonstrated as adjunctive therapy in a randomized, double-blind trial in infants/toddlers 1 to 24 months of age with refractory partial onset seizures Trials in infants/toddlers 1 to 24 months suggested some adverse reactions/toxicities not previously observed in older pediatric patients and adults; i.e, growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. Information added to Warnings and Precautions and Pediatric Use | Labeling | B | - | - | - | Ortho-McNeil-Janssen | 07/24/2008 | FALSE' |
| MESH:D002547 | 07/15/2011 | topamax | topiramate | Monotherapy for partial onset or primary generalized tonic-clonic seizures | Expanded age range down to 2 years; previously approved for monotherapy for partial onset or primary generalized tonic-clonic seizures in patients10 years and older Information on weight based dosing in 2 to < 10 yearsPostmarketing study | Labeling | - | P | - | - | Janssen | - | FALSE' |
| MESH:D002547 | 07/15/2011 | topamax | topiramate | Monotherapy for partial onset or primary generalized tonic-clonic seizures | Expanded age range down to 2 years; previously approved for monotherapy for partial onset or primary generalized tonic-clonic seizures in patients10 years and older Information on weight based dosing in 2 to < 10 yearsPostmarketing study | Labeling | - | P | - | - | Janssen | - | FALSE' |
| MESH:D002547 | 03/28/2014 | topamax | topiramate | Prophylaxis of migraine headache | Approved for use in pediatric patients 12 years and older Safety and effectiveness in pediatric patients less than12 years have not been established for the prophylaxis treatment of migraine headache In the adolescent migraine trials (12 to 17 years), the most commonly observed adverse reactions were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain The most common cognitive adverse reaction in pooled double-blind studies in adolescent patients 12 to 17 years was difficulty with concentration/attention Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated adolescent migraine patients In topiramate-treated patients 12 to 17 years compared to placebo-treated patients, abnormally increased results were more frequent for creatinine, BUN, uric acid, chloride, ammonia, total protein, and platelets. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate Notable changes (increases and decreases) from baseline in systolic blood pressure, diastolic blood pressure, and pulse were observed more commonly in adolescents treated with topiramate compared to adolescents treated with placebo Information on dosing, adverse reactions, laboratory abnormalities, and clinical trials Postmarketing study | Labeling | - | P | - | - | Janssen | - | FALSE' |
| MESH:D002547 | 03/28/2014 | topamax | topiramate | Prophylaxis of migraine headache | Approved for use in pediatric patients 12 years and older Safety and effectiveness in pediatric patients less than12 years have not been established for the prophylaxis treatment of migraine headache In the adolescent migraine trials (12 to 17 years), the most commonly observed adverse reactions were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain The most common cognitive adverse reaction in pooled double-blind studies in adolescent patients 12 to 17 years was difficulty with concentration/attention Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated adolescent migraine patients In topiramate-treated patients 12 to 17 years compared to placebo-treated patients, abnormally increased results were more frequent for creatinine, BUN, uric acid, chloride, ammonia, total protein, and platelets. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate Notable changes (increases and decreases) from baseline in systolic blood pressure, diastolic blood pressure, and pulse were observed more commonly in adolescents treated with topiramate compared to adolescents treated with placebo Information on dosing, adverse reactions, laboratory abnormalities, and clinical trials Postmarketing study | Labeling | - | P | - | - | Janssen | - | FALSE' |
| MESH:D002547 | 10/26/2013 | sabril | vigabatrin | Refractory complex partial seizures (rCPS) | Approved as adjunctive therapy for pediatric patients 10 years and older with rCPS for whom the potential benefits outweigh the risk of vision loss. Sabril is not a first line agent for rCPS Safety and effectiveness for pediatric patients less than 10 years with refractory rCPS have not been established Pooled data from 3 controlled trials in pediatric patients demonstrated that 6% (10/165) of Sabril patients experienced somnolence compared to 5% (5/104) of placebo patients. In those same studies, 10% (17/165) of Sabril patients experienced fatigue compared to 7% (7/104) of placebo patients; 47% (77/163) of Sabril patients versus 19% (19/102) of placebo patients gained greater than or equal to 7% of baseline body weight Adverse reactions (ARs) in the pediatric population were similar to those reported in adults. Overall, ARs in pediatric patients 10-16 years included increased weight, upper respiratory tract infection, tremor, fatigue, aggression and diplopia Information on weight based dosing, dosing in renal impairment, safety information and clinical trials | Labeling | - | - | B,P | - | Lundbeck LLC | 3/10/2013 | FALSE' |
| MESH:D002547 | 10/26/2013 | sabril | vigabatrin | Refractory complex partial seizures (rCPS) | Approved as adjunctive therapy for pediatric patients 10 years and older with rCPS for whom the potential benefits outweigh the risk of vision loss. Sabril is not a first line agent for rCPS Safety and effectiveness for pediatric patients less than 10 years with refractory rCPS have not been established Pooled data from 3 controlled trials in pediatric patients demonstrated that 6% (10/165) of Sabril patients experienced somnolence compared to 5% (5/104) of placebo patients. In those same studies, 10% (17/165) of Sabril patients experienced fatigue compared to 7% (7/104) of placebo patients; 47% (77/163) of Sabril patients versus 19% (19/102) of placebo patients gained greater than or equal to 7% of baseline body weight Adverse reactions (ARs) in the pediatric population were similar to those reported in adults. Overall, ARs in pediatric patients 10-16 years included increased weight, upper respiratory tract infection, tremor, fatigue, aggression and diplopia Information on weight based dosing, dosing in renal impairment, safety information and clinical trials | Labeling | - | - | B,P | - | Lundbeck LLC | 3/10/2013 | FALSE' |
