FDA approvals and recalls

Pediatric: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

New drug approvals

41 new medicines approved (since 1 Jan 2023). Medicines with a new active ingredient that the FDA approved, whose label lists a use on this topic.

At the source

  • Emcitate (tiratricol)

    Approved for: EMCITATE is indicated for the treatment of peripheral thyrotoxicosis in adults and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley sy…

    NDA220963

  • Garzulys (insulin aspart-fsan)

    Approved for: Garzulys™ is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Garzulys is rapid acting human insulin analog indicated to improve glyc…

    BLA761497

  • Isembyld (apitegromab-mstn)

    Approved for: ISEMBYLD is indicated for the treatment of spinal muscular atrophy (SMA) in adults and pediatric patients 2 years of age and older who are currently receiving a survival motor neu…

    BLA761463

  • Zanvastro (zilganersen)

    Approved for: ZANVASTRO is indicated for the treatment of Alexander disease in pediatric and adult patients. ZANVASTRO is a glial fibrillary acidic protein (GFAP)-directed antisense oligonucleo…

    NDA220210

  • Simtriyo (centanafadine hydrochloride)

    Approved for: SIMTRIYO is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older weighing at least 20 kg. Limit…

    NDA218145

  • Ambelvist (gadoquatrane)

    Approved for: AMBELVIST is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascul…

    NDA219627

  • Yuviwel (navepegritide)

    Approved for: YUVIWEL ® is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This indication is approved under accelera…

    NDA219164

  • Loargys (pegzilarginase-nbln)

    Approved for: LOARGYS is indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietar…

    BLA761211

  • Zycubo (copper histidinate)

    Approved for: ZYCUBO is indicated for the treatment of Menkes disease in pediatric patients. ZYCUBO is a copper replacement product indicated for the treatment of Menkes disease in pediatric pa…

    NDA211241

  • Yartemlea (narsoplimab)

    Approved for: YARTEMLEA is indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA…

    BLA761152

  • Exdensur (depemokimab)

    Approved for: EXDENSUR is indicated for the add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Lim…

    BLA761458

  • Kygevvi (doxecitine and doxribtimine)

    Approved for: KYGEVVI is indicated for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years. KYGEVVI is a co…

    NDA219792

  • Forzinity (elamipretide hydrochloride)

    Approved for: FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. This indication is approved under accelerated approv…

    NDA215244

  • Dawnzera (autoinjector) (donidalorsen)

    Approved for: DAWNZERA™ is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. DAWNZERA is a prekallikrein dir…

    NDA219407

  • Modeyso (dordaviprone)

    Approved for: MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease f…

    NDA219876

Source: openFDA, Novel drug approvals (new molecular entities and new biologics), since 1 Jan 2023. Retrieved 12 Nov 2026.

Drug recalls

106 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.

At the source

Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.

Device recalls

206 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

510(k) clearances

19 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.

At the source

Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.

Side effects people report

46 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.

At the source
  1. 1Headache9 reports
  2. 2Vomiting4 reports
  3. 3Anxiety3 reports
  4. 4Drug effective for unapproved indication3 reports
  5. 5Irritability3 reports
  6. 6Nausea3 reports
  7. 7Paediatric acute-onset neuropsychiatric syndrome3 reports
  8. 8Drug intolerance2 reports
  9. 9Dyspnoea2 reports
  10. 10Fatigue2 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

Benchmarks on pediatric

Countries side by side on public measures for this topic.

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Market reports on pediatric

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Public Health

Adolescent Health Public Health Report

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Adolescent Mental Health Public Health Report

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Adolescent Sexual and Reproductive Health Public Health Report

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Autism and Developmental Disorders Public Health Report

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Autism Spectrum Disorder Services

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Birth Asphyxia Public Health Report

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