The latest FDA approvals for children’s medications

Abraham Smith

The Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act have continued to provide us with more US Food and Drug Administration (FDA)-approved medications for pediatric patients and updates in labeling that help us safely and effectively use medications in children. This article summarizes labeling changes, new dosage forms, and new drug approvals from November 2021 to December 2022. Table 1 includes information on newly approved drugs indicated for use in pediatric patients, whereas Table 2 lists newly approved drugs for adults with the potential for use in pediatric patients. Table 3 describes new dosage forms for medications, and Table 4 lists labeling changes to existing drugs with implications for pediatric patients.

The use of biologic therapies for managing chronic pediatric diseases such as atopic dermatitis and asthma has evolved. Adbry (tralokinumab-ldrm)1 is a subcutaneous monoclonal antibody approved for the management of moderate to severe atopic dermatitis in adult patients. Results from clinical studies have demonstrated benefits from scores on the Investigator’s Global Assessment scale and the Eczema Area and Severity Index. Additionally, patients reported improved sleep scores and decreased itch,2 end points affecting the quality of life of patients with atopic dermatitis. Although tralokinumab-ldrm is not yet approved in pediatrics, the plan is to study it in hopes of expanding indications.

Other targets of biologic therapy for atopic dermatitis are the JAK inhibitors. Recent approvals that target the JAK pathway include Opzelura (ruxolitinib), Cibinqo (abrocitinib), and a labeling update to include adolescents for Rinvoq (upadacitinib).2 Approval for these agents was based on clinical outcomes of decreased itch improvements in skin clearance, extent of disease, and severity.3-5 Abrocitinib and upadacitinib are oral agents, and ruxolitinib is a topical agent, providing a more patient-friendly and easier to use dosage formulations for biologics in pediatric patients.

For the management of asthma, the novel agent Tezspire (tezepelumab-ekko) was approved in December 2021 for add-on maintenance management of asthma in adult and pediatric patients 12 years or older. Results from 2 pivotal trials, the Pathway trial and the NAVIGATOR trial (NCT03347279), led to the approval of the drug. Pediatric patients 12 years or older were included in the NAVIGATOR trial. Tezepelumab decreased all-comers exacerbations in the Pathway trial by 71% and by 56% in the NAVIGATOR trial. Decreases in hospitalizations, improvement in forced expiratory volume in the first second, and reductions in blood and sputum eosinophil and fractional exhaled nitric oxide levels were observed. In addition, an overall decrease in exacerbations occurred across all phenotypic styles of asthma. At this point, available biologics work for specific phenotypic styles, so tezepelumab is unique in that it is not phenotype dependent.6

Livtencity (maribavir) was approved in November 2021 and provided a significant advancement in the management of cytomegalovirus (CMV) in adults and pediatric patients 12 years or older weighing 35 kg or more with posttransplant CMV infection or disease refractory to alternative treatment. It has demonstrated efficacy in 56% of patients (n=131/235) compared with those treated with conventional antiviral therapies (24%; n=28/117) (adjusted difference: 33%; 95% CI, 23-43; P<.001).7 Prior to FDA approval, it was granted orphan drug designation by the FDA for management of clinically significant CMV viremia and disease in patients at risk and granted Breakthrough Therapy designation for management of CMV infection and disease in patients who received transplants whose disease was resistant or refractory to prior therapy. It is currently being studied as first-line management of CMV in patients who received stem cell transplants.8 A pediatric study is planned but has not yet started enrolling.9

Recent approval of first-in-class biologic agent Tzield (teplizumab-mzwv) presents a novel approach to the management of type 1 diabetes (T1D), becoming the first drug to delay disease progression. Administered as a single course consisting of once-daily intravenous infusions for 14 consecutive days, this agent is indicated to delay the onset of stage 3 T1D in patients 8 years or older with stage 2 T1D. Approval was based on the results of a phase 2, randomized, double-blind, placebo-controlled trial that demonstrated superior efficacy of teplizumab in delaying onset to diagnosis vs placebo (48.4 vs 24.4 months) in relatives of T1D patients at high risk of developing disease.10,11

Other novel treatments from this year include the approval of several gene therapy cellular products, effectively changing the treatment paradigm for certain chronic diseases. One of these agents, Zynteglo (betibeglogene autotemcel), was approved for the treatment of adult and pediatric patients with β-thalassemia (all genotypes) who require regular red blood cell transfusions. Approval was based on ongoing phase 3 studies, in which 89% of patients achieved transfusion independence for a continuous period of 12 months or greater. This presents a major shift in treatment options for this patient population, potentially eliminating the need for allogeneic hematopoietic stem cell transplantation.12

New drug dosage forms

As more medications continue to receive expanded pediatric indications, new dosage formulations for ease and feasibility of administration have been increasingly in demand. Several new oral liquid preparations were introduced, notably Xarelto (rivaroxaban) 1-mg/mL oral suspension, following pediatric approval in 2021.13 Furthermore, new formulations of preexisting liquid products were introduced for several commonly prescribed medications. Norliqva (amlodipine) 1-mg/mL oral solution presents an alternative to the preexisting amlodipine suspension, Katerzia 1 mg/mL. This new formulation differs in that it does not require shaking upon administration or refrigeration.14,15 To further expand administration options for patients and their caregivers, a new prefilled 40-mg subcutaneous syringe was introduced for Nucala (mepolizumab), indicated for the management of severe eosinophilic asthma. This the first option available for home administration in eligible patients aged 6 to 11 years.16 Lastly, Xelstrym (dextroamphetamine) transdermal patch presents the first topical formulation of dextroamphetamine approved for the management of attention deficit hyperactivity disorder in children 6 years or older.17

Labeling changes

In 2022, we continued to observe expanded indications for younger pediatric age groups. Despite initial clinical off-label use, these updated labels help support the use of medications in children safely and effectively. Below are highlights of some updates of expanded indications in pediatric patients.

Smoflipid (lipid injectable emulsion) has been used in neonates for a few years. Despite a lack of FDA approval, it is used in first-line treatment in many instances. FDA approval for neonates born preterm and at term was based on safety and efficacy evidence from multiple studies ranging from 1 to 4 weeks and one study following neonates beyond 4 weeks.

Multiple medications for HIV, particularly combination products, are now approved for use in younger pediatric patients. Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) and Descovy (emtricitabine/tenofovir alafenamide) are both now approved for pediatric patients aged as young as 2 years. Triumeq PD (abacavir/dolutegravir/lamivudine) is now available in a dispersible tablet and indicated in children who weigh 10 kg or more. Pifeltro (doravirine) tablets and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) tablets are approved in patients who weigh 35 kg or more. Similarly, Cabenuva (cabotegravir/rilpivirine) injection and Vocabria (cabotegravir) tablets are new agents approved for use in patients 12 years or older and have expanded labels for pediatric patients who weigh 35 kg or more.18,19

Conclusion

Novel treatments approved in 2022 provide improved therapies for patients with acute and chronic illnesses. For the pediatric patient population, novel therapies have the potential to change the long-term outcomes of chronic diseases such as T1D. New gene therapies have transformed the management of certain diseases. We continue to gain more information on the use of medications in pediatric patients through labeling changes.

Tzield (teplizumab-mzwv)10

Disease-modifying diabetic agent, monoclonal antibody

To delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years or older who currently have stage 2 type 1 diabetes

For use with MRI to detect and visualize lesions with abnormal vascularity in the CNS and body in adult and pediatric patients 2 years or older

Xenpozyme (olipudase alfa-rpcp)21

Enzyme replacement therapy

Hydrolytic lysosomal sphingomyelin–specific enzyme for management of non-CNS manifestations of acid sphingomyelinase deficiency in adults and pediatric patients

For the management of seizures associated with CDKL5 deficiency disorder in patients 2 years or older

Tezspire (tezepelumab-ekko)6

For management of severe asthma as add-on maintenance therapy in adults and pediatric patients 12 years and older

For management of post-transplant CMV infection/disease that is refractory to management (with or without genotypic resistance) with ganciclovir,valganciclovir, cidofovir, or foscarnet in adults and pediatric patients 12 years or older who weigh 35 kg or more

To improve growth with achondroplasia and open epiphyses in patients 5 years or older

For management of cholestatic pruritus in patients 1 year or older with Alagille syndrome

Xelstrym transdermal system (dextroamphetamine)17

For pediatric patients aged 6 to 17 years with ADHD

Opdualag (nivolumab and relatlimab-rmbw)25

For reduction of the risk of ototoxicity associated with cisplatin in pediatric patients 1 month or older with localized, nonmetastatic solid tumors

Pedmark (sodium thiosulfate)28

For reduction of the risk of ototoxicity associated with cisplatin in pediatric patients 1 month or older with localized, nonmetastatic solid tumors

Skysona (elivaldogene autotemcel)27

Autologous hematopoietic stem cell, self-inactivating Lenti-D lentiviral vector

To slow the progression of neurologic dysfunction in boys aged 4 to 17 years with early, active CALD

Zyntelgo (betibeglogene autotemcel)12

Autologous hematopoietic stem cell–based gene therapy

For the treatment of adults and pediatric patients with β-thalassemia who require regular RBC transfusions

Priorix (measles, mumps, and rubella vaccine, live)28

For active immunization to prevent measles, mumps, and rubella in patients 1 year or older.

ADHD, attention deficit hyperactivity disorder; CALD, cerebral adrenoleukodystrophy; CMV, cytomegalovirus; CNS, central nervous system; RBC, red blood cell.

Rolvedon (eflapegrastim-xnst)29

To decrease the incidence of infection with nonmyeloid malignant tumors in adults

Sotyktu (deucravacitinib)30

For the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Spevigo (spesolimab-sbzo)31

Dermatologic agent, IL inhibitor

For the management of generalized pustular psoriasis flares in adults

For the management of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

For topical management of plaque psoriasis in adults

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

For the management of hemolytic anemia in adults with PKR deficiency

Enjaymo (sutimlimab-jome)36

To decrease the need for red blood cell transfusion because of hemolysis with cold agglutinin disease in adults

Dermatologic agent, JAK inhibitor

Management of refractory, moderate to severe atopic dermatitis in adults whose disease is not adequately controlled with other therapies

For the management of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults

Adbry (tralokinumab-ldrm)1

Dermatologic agent, IL inhibitor

For management of moderate to severe AD in adults whose disease is not well controlled with topical prescription therapies

Small interfering RNA therapy

To manage heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy in adults

Besremi (ropeginterferon alfa-2b-njft)39

For management of polycythemia vera in adults

Peptide receptor antagonist

For the preventive management of episodic migraine in adults

Rebyota (fecal microbiota, live-jslm)41

Suspension for rectal use

For prevention of recurrence of CDI in adults following antibiotic treatment

Hemgenix (etranacogene dezaparvovec-drlb)42

Adeno-associated virus vector-based gene therapy

For treatment of adults with hemophilia B (congenital factor IX deficiency) who currently use factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes

AD, atopic dermatitis; CDI, Clostridioides difficile infection.

40-mg prefilled syringe for home administration

For treatment of children aged 6 to 11 years who have severe eosinophilic asthma

Takhzyro (lanadelumab-flyo)43

300-mg/2-mL prefilled syringe

For prevention of hereditary angioedema attacks in children 12 years and older

For management of human smallpox disease

Menveo (meningococcal [groups A, C, Y, and W-135]oligosaccharide diptheria CRM197 conjugate vaccine)45

For prevention of meningococcal disease in children 10 years and older

Rotarix (rotavirus vaccine, live, oral)46

For prevention of rotavirusgastroenteritis caused by G1 and non-G1 types (G3, G4 and G9) in infants

Oral suspension (1 mg/mL)

For management of VTE and reduction in the risk of recurrent VTE in pediatric patients and thromboprophylaxis in pediatric patients 2 years or older with congenital heart disease after the Fontan procedure

Oral suspension (70 mg/mL)

For treatment of pediatric patients 1 year or older with cGVHD after failure of 1 or more lines of systemic therapy

Triumeq PD (abacavir/dolutegravir/lamivudine)48

For management of HIV-1 infection in patients weighing 10 kg or more

Oral suspension (5 mg/mL)

For the management of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity

For the management of hypertension in children 6 years or older

Oral solution (100 mg/5 mL)

For adjunctive therapy in patients 16 years or older with epilepsy

Thyroid hormone replacement

For management of hypothyroidism and pituitary thyrotropin suppression in adults and pediatric patients, including neonates

cGVHD, chronic graft-vs-host disease; VE, venous thromboembolism.

For management of obesity in adults

Approved in patients 12 years or older

Potassium channel blocker

For management of LEMS in adults

Approved in pediatric patients 6 years or older

Lyumjev (insulin lispro-aabc)

For treatment of adults with type 1 and type 2 diabetes

Approved in children with diabetes 1 year or older

Orkambi (lumacaftor/ivacaftor)

Cystic fibrosis transmembrane regulator

For treatment of patients aged 2-5 years with cystic fibrosis who have 2 F508del mutations

Approved in patients aged 12-14 months

For treatment of patients 6 years or older with moderate to severe atopic dermatitis and adults with eosinophilic esophagitis

Safety and effectiveness established in pediatric patients 6 months or older with moderate to severe atopic dermatitis and in patients 12 years or older for eosinophilic esophagitis

For the management of active psoriatic arthritis in adults

Approved in pediatric patients 6 years or older

Xofluza (baloxavir marboxil)

For postexposure prophylaxis of influenza in adults

Approved in patients 5 years or older

For management of seizures associated with Dravet syndrome in patients 2 years or older

Approved for additional indication of management of seizures associated with Lennox-Gastaut syndrome in patients 2 years or older

For the management of active lupus nephritis in adults

Approved for the treatment of children aged 5-17 years

Three-day regimen for the prevention of nausea and vomiting in adults

Approved in pediatric patients aged 6 months to 17 years

Zerbexa (ceftolozane/tazobactam)

For the management of complicated intraabdominal infections and complicated urinary tract infections in adults (safety and effectiveness established)

Approved in all pediatric patients

Triumeq (abacavir/dolutegravir/lamivudine52

For management of HIV-1 infection in adult patients

For the management of HIV-1 infection in patients weighing 25 kg or more

Comirnaty (COVID-19 vaccine, mRNA)

For active immunization to prevent COVID-19 caused by SARS-CoV-2 in patients 16 years or older

Approved in patients aged 12-15 years

Qsymia (phentermine/ topiramate)

For management of chronic weight in adult patients in addition to a reduced-calorie diet and exercise

Approved for management of chronic weight in pediatric patients 12 years or older who have obesity, defined as a BMI of 95th percentile or greater when standardized for age and sex

Vaxneuvance (pneumococcal 15-valent conjugate vaccine)

For the prevention of pneumococcal disease in adults

Approved for the prevention of pneumococcal disease in patients 2 months or older

For the management of refractory, moderate to severe atopic dermatitis in patients whose disease is not adequately controlled with other systemic drug products including biologics or when use of those therapies is inadvisable

Approved in patients 12 years or older

For the management of COVID-19 in adults who are hospitalized or not hospitalized and are at high risk for progression to severe COVID-19, including hospitalization or death

Approved in pediatric patients 28 days or older and weighing 3 kg or more

For the management of spinal muscular atrophy in patients 2 months or older

Approved in all patients with spinal muscular atrophy

CellCept (mycophenolate mofetil)

For the prophylaxis of organ rejection in adults with heart or liver transplants and in adult and pediatric patients with kidney transplants in combination with other immunosuppressants

Expanded indication to include pediatric patients 3 years or older with liver and heart transplants

For anticoagulation in all adult patients

Indicated for the management of VTE and reduction in the risk of recurrent VTE in pediatric patients after 5 days or more of initial parenteral (injected or intravenous) anticoagulant treatment and for thromboprophylaxis (prevention of blood clots and blood clot–related events) in children 2 years or older with congenital heart disease who have undergone the Fontan procedure

Smoflipid (lipid injectable emulsion)

For adult patients as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated

Expanded indication to all pediatric patients including neonatal patients born at term and preterm

NephroScan kit (technetium Tc99m succimer)

Indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders

Indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in pediatric patients, including neonates born at term

Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide)

For the management of HIV-1 in patients 6 years or older

Management of HIV-1 in patients 2 years or older

Descovy (emtricitabine/tenofovir alafenamide)

For the management of HIV-1 in patients weighing 35 kg or more

Management of HIV-1 infection in pediatric patients 2 years or older weighing 14 kg or more

Ryaltris nasal spray (olopatadine hydrochloride/mometasone furoate)

For management of symptoms associated with seasonal allergic rhinitis in adults

Indicated for pediatric patients 12 years or older

Solosec oral granules (secnidazole)

For management of trichomoniasis and bacterial vaginosis in adults

Indicated for pediatric patients 12 years or older

Pifeltro tablets (doravirine)

For management of HIV-1 infection in adults

Indicated for pediatric patients weighing 35 kg or more

Delstrigo tablets (doravirine/lamivudine/tenofovir disoproxil fumarate)

For management of HIV-1 infection in adults

Indicated for pediatric patients weighing 35 kg or more

Opdualag injection (nivolumab/relatlimab-rmbw)

For management of unresectable or metastatic melanoma in adults

Indicated for pediatric patients 12 years or older weighing 40 kg or more

For the management of CLL in adults

Indicated for pediatric patients 1 year or older with cGVHD after failure of 1 or more lines of systemic therapy

Cabenuva injection (cabotegravir/rilpivirine)

For management of HIV-1 infection in adults

Indicated for pediatric patients 12 years or older weighing 35 kg or more

Vocabria tablets (cabotegravir)

For management and preexposure prophylaxis of HIV-1 infection in adults

Indicated for adolescents 12 years or older weighing 35 kg or more

Zulresso injection (brexanolone)

Antiviral agentAntiviral agent

For management of postpartum depression in adults

Indicated for patients 15 years or older

Halaven injection (eribulin mesylate)

For management of metastatic breast cancer and liposarcoma in adult patients

Treatment of pediatric patients with relapsed or refractory solid tumors and lymphomas

For treatment of adults with MDS subtypes: RA or RARS and CMMoL

Treatment of pediatric patients 1 month or older with newly diagnosed JMML

For the treatment of adults with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as single agent and in combination with dabrafenib

Management (in combination with dabrafenib) of unresectable or metastatic solid tumors with BRAF V600E mutation that have progressed following prior treatment in adults and children 6 years and older

For the management of adults with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as single agent and in combination with trametinib

Management (in combination with trametinib) of unresectable or metastatic solid tumors with BRAF V600E mutation that have progressed following prior treatment in adults and children 6 years and older

For the treatment of patients with metastatic NSCLC whose tumors are ALK+ or ROS1+

Treatment of adults and pediatric patients 1 year or older with unresectable, recurrent, or refractory IMT that is ALK+

Adcetris (brentuximab vedotin)

For management (in combination with chemotherapy) of adult Hodgkin and anaplastic large cell lymphoma and of cHL at high risk of relapse or progression as post autologous HSCT consolidation

Treatment of pediatric patients 2 years or older with previously unmanaged high-risk cHL in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide

For management of metastatic NSCLC in adults who experience disease progression during or following platinum-containing chemotherapy

As a single agent for the treatment of adult and pediatric patients 2 years or older with unresectable or metastatic ASPS

ASPS, alveolar soft part sarcoma; BMI, body mass index; cGVHD, chronic graft-vs-host disease; cHL, classical Hodgkin lymphoma; CLL, chronic lymphocytic leukemia; CMMoL, chronic myelomonocytic leukemia; HSCT, hematopoietic stem cell transplantation; IMT, inflammatory myofibroblastic tumor; JMML, juvenile myelomonocytic leukemia; LEMS, Lambert-Eaton myasthenic syndrome; MDS, myelodysplastic syndrome; NSCLC, non–small cell lung cancer; RA, refractory anemia; RARS, RA with ring sideroblasts.

References

  1. Adbry. Prescribing information. LEO Pharma Inc; 2021. Accessed December 28, 2022. https://mc-df05ef79-e68e-4c65-8ea2-953494-cdn-endpoint.azureedge.net/-/media/corporatecommunications/us/therapeutic-expertise/our-product/adbrypi.pdf?rev=9d9413564f5449e283dac3bc4c5be53a
  2. Li H, Zhang Z, Zhang H, Guo Y, Yao Z. Update on the pathogenesis and therapy of atopic dermatitis. Clin Rev Allerg Immunol. 2021;61(3):324-338. doi:10.1007/s12016-021-08880-3
  3. Opzelura. Prescribing information. Incyte; 2021. Accessed December 28, 2022. https://www.opzelura.com/prescribing-information.pdf
  4. Cibinqo. Prescribing information. Pfizer; 2022. Accessed December 28, 2022. https://labeling.pfizer.com/ShowLabeling.aspx?id=16652
  5. Rinvoq. Prescribing information. AbbVie Inc; 2022. Accessed December 28, 2022. https://www.rxabbvie.com/pdf/rinvoq_pi.pdf
  6. Tezspire. Prescribing information. AstraZeneca; 2021. Accessed December 28, 2022. https://den8dhaj6zs0e.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/e306dc06-d580-4457-b15f-9f28545ad63a/e306dc06-d580-4457-b15f-9f28545ad63a_viewable_rendition__v.pdf
  7. Livtencity. Prescribing information. Takeda Pharmaceuticals USA Inc; 2022. Accessed December 28, 2022. https://content.takeda.com/?contenttype=pi&product=liv&language=eng&country=usa&documentnumber=1
  8. Azevedo LS, Pierrotti LC, Abdala E, et al. Cytomegalovirus infection in transplant recipients. Clinics (Sao Paulo). 2015;70(7):515-523. doi:10.6061/clinics/2015(07)09
  9. A study of maribavir compared to valganciclovir to treat cytomegalovirus infections in people who have received stem cell transplants. ClinicalTrials.gov. Updated July 6, 2022. Accessed September 20, 2022. https://clinicaltrials.gov/ct2/show/NCT02927067
  10. Tzield. Prescribing information. Provention Bio Inc; 2022. Accessed January 6, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761183s000lbl.pdf
  11. Herold KC, Bundy BN, Long SA, et al. An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes. N Engl J Med. 2019;381(7):603-613. doi:10.1056/NEJMoa1902226
  12. Zynteglo. Prescribing information. bluebird bio Inc; 2022. Accessed December 22, 2022. https://www.fda.gov/media/160991/download
  13. Xarelto. Prescribing information. Janssen Pharmaceuticals Inc; 2021. Accessed December 22, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215859s000lbl.pdf
  14. Norliqva. Prescribing information. CMP Pharma Inc; 2022. Accessed December 16, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214439s000lbl.pdf
  15. Katerzia. Prescribing information. Azurity Pharmaceuticals Inc; 2020. Accessed December 16, 2022. https://katerzia.com/Katerzia-Prescribing-Info.pdf
  16. Nucala. Prescribing information. GSK; 2022. Accessed December 16, 2022. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-COMBINED.PDF
  17. Xelstrym. Prescribing information. Noven; 2022. Accessed December 22, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215401s000lbl.pdf
  18. Pediatric labeling changes. FDA. Updated August 30, 2022. Accessed January 2, 2023. https://www.fda.gov/science-research/pediatrics/pediatric-labeling-changes
  19. Pediatric oncology drug approvals. FDA. Updated December 2022. Accessed January 6, 2023. https://www.fda.gov/about-fda/oncology-center-excellence/pediatric-oncology-drug-approvals
  20. Elucirem. Prescribing information. Liebel-Flarsheim Company LLC; 2022. Accessed December 22, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216986s000lbl.pdf
  21. Xenpozyme. Prescribing information. Genzyme; 2022. Accessed December 22, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761261s000lbl.pdf
  22. Ztalmy. Prescribing information. Marinus Pharmaceuticals Inc; 2022. Accessed December 22, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215904s000lbl.pdf
  23. Voxzogo. Prescribing information. Biomarin Pharmaceutical Inc; 2021. Accessed December 22, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214938s000lbl.pdf
  24. Livmarli. Prescribing information. Mirum Pharmaceuticals Inc; 2021. Accessed December 22, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214662s000lbl.pdf
  25. Opdualag. Prescribing information. Bristol-Myers Squibb; 2022. Accessed December 22, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761234s000lbl.pdf
  26. Pedmark. Prescribing information. Fennec Pharmaceuticals Inc; 2022. Accessed December 22, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212937s000lbl.pdf
  27. Skysona. Prescribing information. bluebird bio Inc; 2022. Accessed December 22, 2022. https://www.fda.gov/media/161640/download
  28. Priorix. Prescribing information. GSK; 2022. Accessed December 22, 2022. https://www.fda.gov/media/158941/download
  29. Rolvedon. Prescribing information. Spectrum Pharmaceuticals Inc; 2022. Accessed December 22, 2022. https://www.rolvedon.com/pdf/rolvedon-prescribing-information.pdf
  30. Sotyktu. Prescribing information. Bristol-Myers Squibb; 2022. Accessed December 22, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214958s000lbl.pdf
  31. Spevigo. Prescribing information. Boehringer Ingelheim Pharmaceuticals Inc; 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761244s000lbl.pdf
  32. Amvuttra. Prescribing information. Alnylam Pharmaceuticals Inc; 2022. Accessed December 23, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215515s000lbl.pdf
  33. Vtama. Prescribing information. Dermavant Sciences Inc; 2022. Accessed December 23, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215272s000lbl.pdf
  34. Mounjaro. Prescribing information. Eli Lilly; 2022.Accessed December 23, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215866s000lbl.pdf
  35. Pyrukynd. Prescribing information. Agios Pharmaceuticals Inc; 2022. Accessed December 23, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216196s000lbl.pdf
  36. Enjaymo. Prescribing information. Bioverativ USA Inc; 2022. Accessed December 24, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761164s000lbl.pdf
  37. Quviviq. Prescribing information.Idorsia Pharmaceuticals US Inc; 2022. Accessed December 24, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214985s000lbl.pdf
  38. Leqvio. Prescribing information. Novartis Pharmaceuticals Corp; 2021. Accessed December 24, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214012lbl.pdf
  39. Besremi. Prescribing information. PharmaEssentia Corp; 2021. Accessed December 24, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761166s000lbl.pdf
  40. Qulipta. Prescribing information. AbbVie Inc; 2021. Accessed December 24, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215206Orig1s000lbl.pdf
  41. Rebyota. Prescribing information. Ferring Pharmaceuticals Inc; 2022. Accessed December 24, 2022. https://www.rebyota.com/?gclid=Cj0KCQiAq5meBhCyARIsAJrtdr6EqFum8JrcC20kTEu5BxEXaWAPM21OKJ6mA7GbJC__Xzumtrz4MX0aAhRPEALw_wcB&gclsrc=aw.ds
  42. Hemgenix. Prescribing information. CSL Behring LLC; 2022. Accessed December 24, 2022. https://www.fda.gov/media/163467/download
  43. Takhzyro. Prescribing information. Takeda Pharmaceuticals USA Inc; 2022. Accessed December 22, 2022. https://www.shirecontent.com/PI/PDFs/TAKHZYRO_USA_ENG.pdf
  44. Tpoxx. Prescribing information. SIGA Technologies Inc; 2022. Accessed December 22, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214518s000lbl.pdf
  45. Menveo. Prescribing information. GSK; 2022. Accessed December 22, 2022. https://www.fda.gov/media/78514/download
  46. Rotarix. Prescribing information. GSK; 2022. Accessed December 22, 2022. https://www.fda.gov/media/75726/download
  47. Imbruvica. Prescribing information. Pharmacyclics LLC; 2022. Accessed December 22, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/217003s000lbl.pdf
  48. Triumeq. Prescribing information. GSK; 2022. Accessed December 22, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215413s000lbl.pdf
  49. Fleqsuvy. Prescribing information. Azurity Pharmaceuticals Inc; 2022. Accessed December 16, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215602s000lbl.pdf
  50. Zonisade. Prescribing information. Azurity Pharmaceuticals Inc; 2022. Accessed December 22, 2022. https://zonisade.com/wp-content/uploads/2022/09/22-2001-32115_Zonisade_PI_Proof-1_R10_Final.pdf
  51. Ermeza. Prescribing information. Mylan Pharmaceuticals Inc; 2022. Accessed December 16, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215809s000lbl.pdf

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