FDA labeling changes(Total Drugs:13) |
|---|
| 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:D011693 | 03/25/2004 | cipro | ciprofloxacin | Complicated UTI and pyelonephritis | Indicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1 17 years of age Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues Information on PK and dose in pediatric patients 1 17 years of age The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectively | Labeling | B | - | - | - | Bayer | 12/18/2003 | FALSE' |
| MESH:D011693 | 03/25/2004 | cipro | ciprofloxacin | Complicated UTI and pyelonephritis | Indicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1 17 years of age Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues Information on PK and dose in pediatric patients 1 17 years of age The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectively | Labeling | B | - | - | - | Bayer | 12/18/2003 | FALSE' |
| MESH:D011693 | 08/19/2004 | vioxx | rofecoxib | Pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis | Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) due to safety concerns on September 30, 2004. | Labeling | B | - | - | - | Merck | 02/18/2004 | FALSE' |
| MESH:D011693 | 08/19/2004 | vioxx | rofecoxib | Pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis | Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) due to safety concerns on September 30, 2004. | Labeling | B | - | - | - | Merck | 02/18/2004 | FALSE' |
| MESH:D011693 | 08/19/2004 | vioxx | rofecoxib | Pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis | Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) due to safety concerns on September 30, 2004. | Labeling | B | - | - | - | Merck | 02/18/2004 | FALSE' |
| MESH:D011693 | 09/27/2006 | gleevec | imatinib mesylate | Treatment of newly diagnosed pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase | Extended age range for the treatment of newly diagnosed CML down to pediatric patients There are no data in children < 2 years of age Follow-up in children with newly diagnosed Ph+ chronic phase CML is limited Information on hematologic toxicities, AE profile, clinical studies and dosing guidelines new for newly diagnosed pediatric patients | Labeling | - | - | B, P | - | Novartis | 9/6/2006 | FALSE' |
| MESH:D011693 | 09/27/2006 | gleevec | imatinib mesylate | Treatment of newly diagnosed pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase | Extended age range for the treatment of newly diagnosed CML down to pediatric patients There are no data in children < 2 years of age Follow-up in children with newly diagnosed Ph+ chronic phase CML is limited Information on hematologic toxicities, AE profile, clinical studies and dosing guidelines new for newly diagnosed pediatric patients | Labeling | - | - | B, P | - | Novartis | 9/6/2006 | FALSE' |
| MESH:D011693 | 1/10/2009 | mirena | levonorgestrel-releasing intrauterine system | Treatment of heavy menstrual bleeding for women using intrauterine contraception | New indication for the treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception Use before menarche is not indicated | Labeling | - | P | - | - | Berlex | - | TRUE' |
| MESH:D011693 | 10/7/2009 | plan b one step | levonorgestrel | Emergency contraception - OTC in women 17 years and older; RX for women younger than age 17 years | New single dose 1.5 mg tablet New dosage regimen | Labeling | - | P | - | - | Duramed | - | FALSE' |
| MESH:D011693 | 2/11/2010 | ofirmev | acetaminophen | Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever | The safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and olderMost common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.Information on dosing, clinical studies, adverse reactions and PK parametersNew dosage form and route of administration | Labeling | - | P | - | - | Cadence | - | FALSE' |
| MESH:D011693 | 01/27/2017 | ofirmev | acetaminophen | Treatmeny of pain and fever in pediatric patients birth to 2 years | Treatment of pain Efficacy was not demonstrated in pediatric patients younger than 2 years in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. Pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. No difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control, was observed. Treatment of fever The safety and effectiveness for the treatment of fever in pediatric patients, including premature neonates born at 32 weeks or greater gestation is supported by adequate and well-controlled studies of Ofirmev in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates 32 weeks or greater gestational age. Information on dosing, clinical trials. Postmarketing study. | Labeling | - | - | B,P | - | Mallinckrodt | 11/7/2016 | FALSE |
| MESH:D011693 | 2/11/2010 | ofirmev | acetaminophen | Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever | The safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and olderMost common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.Information on dosing, clinical studies, adverse reactions and PK parametersNew dosage form and route of administration | Labeling | - | P | - | - | Cadence | - | FALSE' |
| MESH:D011693 | 01/27/2017 | ofirmev | acetaminophen | Treatmeny of pain and fever in pediatric patients birth to 2 years | Treatment of pain Efficacy was not demonstrated in pediatric patients younger than 2 years in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. Pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. No difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control, was observed. Treatment of fever The safety and effectiveness for the treatment of fever in pediatric patients, including premature neonates born at 32 weeks or greater gestation is supported by adequate and well-controlled studies of Ofirmev in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates 32 weeks or greater gestational age. Information on dosing, clinical trials. Postmarketing study. | Labeling | - | - | B,P | - | Mallinckrodt | 11/7/2016 | FALSE |
