Congenital Hypothyroidism
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS research · 2026-03-12Clinical Trial Update: Role of Next Generation Sequencing in the Etiological Diagnosis of Permanent Congenital Hypothyroidism With in Situ Thyroid
This clinical trial investigates the role of next-generation sequencing in determining the etiological causes of permanent congenital hypoth…
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CLINICAL_TRIALS research · 2026-03-12Clinical Trial Update: Comparison of Levothyroxine Formulations in the Treatment of Congenital Hypothyroidism
The clinical trial update indicates recruitment is ongoing for a study comparing levothyroxine formulations in congenital hypothyroidism.
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CLINICAL_TRIALS research · 2026-02-20Clinical Trial Update: Evaluation of an Intensified Systematic Screening for Congenital Hypothyroidism in Premature Newborns
A clinical trial evaluating an intensified systematic screening approach for congenital hypothyroidism in premature newborns to assess feasi…
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CLINICAL_TRIALS research · 2026-02-12Clinical Trial Update: Infants With Primary Congenital Hypothyroidism and Development
A clinical trial investigating development in infants with primary congenital hypothyroidism is currently recruiting.
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CLINICAL_TRIALS trial_result · 2025-10-23Clinical Trial Update: Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH) [Phase 4]
A Phase 4 pediatric trial evaluating Tirosint-SOL and tablet formulations of levothyroxine for congenital hypothyroidism was terminated.
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CLINICAL_TRIALS research · 2025-09-08Clinical Trial Update: Clinical and Genetic Analysis in Congenital Hypothyroidism Due to Thyroid Dysgenesis. [NA]
This update reports on a completed clinical study examining clinical and genetic factors in congenital hypothyroidism caused by thyroid dysg…
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CLINICAL_TRIALS research · 2025-09-03Clinical Trial Update: Prospective Evaluation of OptiThyDose [NA]
A prospective evaluation of OptiThyDose for thyroid conditions, including congenital hypothyroidism and Graves' disease, is currently recrui…
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CLINICAL_TRIALS research · 2025-08-17Clinical Trial Update: Metabolic Risk Assessment in Prepubertal Children With Congenital Hypothyroidism
A clinical trial sponsored by Buzzi Children's Hospital is evaluating metabolic risk assessment in prepubertal children with congenital hypo…
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CLINICAL_TRIALS trial_result · 2025-08-12Clinical Trial Update: Baby Detect : Genomic Newborn Screening
Clinical trial update on the Baby Detect genomic newborn screening program, reporting completion of a study assessing screening for multiple…
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CLINICAL_TRIALS research · 2025-03-07Clinical Trial Update: Quality of Life and Long-term Outcome of Adequately Treated Congenital Hypothyroidism [NA]
This update indicates ongoing enrollment for a study assessing quality of life and long-term outcomes in individuals with adequately treated…
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FDA approval · 2025-03-05FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Fosun Pharma USA Inc.)
FDA approves Fosun Pharma USA Inc.'s Levothyroxine Sodium anhydrous as a generic product under Original ANDA for thyroid hormone replacement…
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FDA approval · 2023-11-16FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Alvogen, Inc.)
The FDA approved a supplemental application for Levothyroxine Sodium by Alvogen, Inc., updating the regulatory status for this product under…
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FDA approval · 2023-07-21FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for Levothyroxine Sodium, a generic product used to treat hypothyroidism and re…
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FDA label_change · 2023-07-20FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA supplemental application filed for Levothyroxine Sodium by Mylan Pharmaceuticals Inc., an approved generic, likely to address labeling c…
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FDA approval · 2022-12-21FDA Approved: LEVOTHYROXINE SODIUM — Original Application (NorthStar RxLLC)
FDA approved the original application for levothyroxine sodium as a generic thyroid hormone replacement product from NorthStar RxLLC.
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FDA approval · 2022-10-31FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for levothyroxine sodium from Accord Healthcare Inc. under an ANDA.
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CLINICAL_TRIALS trial_result · 2022-05-12Clinical Trial Update: Influence of Initial Levothyroxine Dose on Neurodevelopmental and Growth Outcomes in Congenital Hypothyroidism [Phase 4]
Phase 4 trial examining how the initial levothyroxine dose affects neurodevelopment and growth in congenital hypothyroidism.
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FDA approval · 2022-05-10FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved Teva’s generic levothyroxine sodium product under an Original Application (ANDA 207588).
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FDA approval · 2021-05-17FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a Levothyroxine Sodium original application product from Hikma Pharmaceuticals USA Inc. as a thyroid hormone replacement therap…
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FDA approval · 2020-10-19FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Accord Healthcare Inc.)
FDA approved an original application for Levothyroxine Sodium from Accord Healthcare Inc. as a generic thyroid hormone replacement product.
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FDA label_change · 2020-07-15FDA Approved: SYNTHROID — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for Synthroid (levothyroxine sodium) by AbbVie, resulting in a labeling change. The action updates t…
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FDA approval · 2019-04-23FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Alvogen, Inc.)
FDA approved a supplemental application for Levothyroxine Sodium (Alvogen, Inc.), authorizing changes to the product labeling.
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FDA approval · 2019-04-11FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Fresenius Kabi USA, LLC)
The FDA approved a new Levothyroxine sodium product from Fresenius Kabi USA, LLC under its Original Application. Levothyroxine is a thyroid …
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FDA approval · 2019-01-18FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' generic levothyroxine sodium as an original application, authorizing its use as a thyroid hormone replac…
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FDA approval · 2018-12-10FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for levothyroxine sodium from Amneal Pharmaceuticals NY LLC.