Congenital Hypothyroidism
📧 Sign up to get email alerts when something new happens for Congenital Hypothyroidism.
Sign up freeTop drugs studied for this disease
-
CLINICAL_TRIALS trial_result · 2018-02-23Clinical Trial Update: Generic vs. Name-Brand Levothyroxine [NA]
Completed clinical trial comparing generic vs name-brand levothyroxine with results posted in 2018.
-
FDA approval · 2017-12-08FDA Approved: TIROSINT — Supplemental Application (IBSA Pharma Inc.)
The FDA approved a supplemental application for TIROSINT (levothyroxine sodium) by IBSA Pharma Inc., updating the product labeling as part o…
-
CLINICAL_TRIALS trial_result · 2017-12-04Clinical Trial Update: A Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron in Patients With Thyroid Scan Indication
This completed clinical trial evaluated producing technetium-99m pertechnetate in a high-energy cyclotron for use in thyroid scans in patien…
-
CLINICAL_TRIALS trial_result · 2017-10-09Clinical Trial Update: Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism [NA]
Completed clinical trial evaluating targeted levothyroxine dosing in infants with congenital hypothyroidism; results have been posted.
-
CLINICAL_TRIALS trial_result · 2017-05-03Clinical Trial Update: The Reduced Thyroid Function of the Premature Newborn: Relation With Molecular Changes in the Placenta and Maternal Thyroid Hormone Status and Neurodevelopmental Implications
This clinical trial update describes reduced thyroid function in premature newborns and investigates how placental molecular changes and mat…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2017-02-24FDA Approved: TIROSINT SOL — Supplemental Application (IBSA Pharma Inc.)
The FDA approved a supplemental application for TIROSINT SOL (levothyroxine sodium) from IBSA Pharma Inc., a thyroid hormone replacement the…
-
FDA label_change · 2017-02-23FDA Approved: SYNTHROID — Supplemental Application (AbbVie Inc.)
FDA approved a labeling supplement for Synthroid (levothyroxine sodium) submitted by AbbVie, updating the drug’s labeling.
-
FDA approval · 2017-01-12FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Lannett Company, Inc)
The FDA approved a supplemental application for Levothyroxine Sodium from Lannett Company, Inc, enabling the marketed generic product.
-
FDA approval · 2016-06-29FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Piramal Critical Care, Inc.)
FDA approved Piramal Critical Care's levothyroxine sodium as an original application (ANDA206163), providing a generic option for thyroid ho…
-
FDA approval · 2015-11-09FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Alvogen, Inc.)
FDA approved a Supplemental Application for Levothyroxine Sodium from Alvogen, Inc. to continue regulatory recognition of the drug under its…
-
CLINICAL_TRIALS withdrawal · 2015-07-08Clinical Trial Update: The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism
The clinical trial examining the prevalence of hearing loss among children with congenital hypothyroidism has been withdrawn.
-
FDA approval · 2015-02-09FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Lannett Company, Inc)
The FDA approved a supplemental application for LEVOTHYROXINE SODIUM from Lannett Company, Inc., updating or expanding the labeling for the …
-
FDA approval · 2012-11-20FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Lannett Company, Inc)
FDA approved a supplemental application for levothyroxine sodium from Lannett Company, Inc., supporting the generic product's continued mark…
-
CLINICAL_TRIALS research · 2012-08-17Clinical Trial Update: Clinical Evaluation of NeoPlex4 Assay and NeoPlex System
This update notes the completed clinical evaluation of Luminex's NeoPlex4 Assay and NeoPlex System, assessing tests for congenital adrenal h…
-
FDA approval · 2011-03-09FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Lannett Company, Inc)
FDA approved the supplemental application for Levothyroxine Sodium from Lannett Company, Inc, authorizing the marketing of this generic prod…
-
FDA label_change · 2009-09-01FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA has approved a supplemental application for levothyroxine sodium from Amneal Pharmaceuticals NY LLC, updating labeling and related regul…
-
FDA approval · 2008-10-30FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for levothyroxine sodium from Mylan Pharmaceuticals Inc., granting regulatory approval for this gene…
-
FDA approval · 2008-06-10FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Lannett Company, Inc)
The FDA approved a supplemental application for levothyroxine sodium submitted by Lannett Company, Inc., authorizing continued marketing of …
-
FDA approval · 2007-12-17FDA Approved: TIROSINT — Supplemental Application (IBSA Pharma Inc.)
FDA approved a supplemental application for TIROSINT (levothyroxine sodium) submitted by IBSA Pharma Inc., expanding the regulatory approval…
-
CLINICAL_TRIALS research · 2007-07-23Clinical Trial Update: Iodine Status in Pregnant Women and Their Newborns: is Congenital Hypothyroidism Related to Iodine Deficiency in Pregnancy?
A clinical trial update examining iodine status in pregnant women and the potential link to congenital hypothyroidism in newborns. The curre…
-
CLINICAL_TRIALS research · 2007-07-06Clinical Trial Update: Diagnosis and Follow-up of Patients With Subclinical Hypothyroidism
Clinical trial update on diagnosis and follow-up of patients with subclinical hypothyroidism, including congenital hypothyroidism and levoth…
-
CLINICAL_TRIALS trial_result · 2007-06-27Clinical Trial Update: TG Gene Mutations and Congenital Hypothyroidism
This completed clinical trial from the University of Sao Paulo investigated thyroglobulin (TG) gene mutations as a cause of congenital hypot…
-
FDA approval · 2006-12-13FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Levothyroxine Sodium from Mylan Pharmaceuticals Inc. (ANDA 076187).
-
FDA approval · 2006-10-13FDA Approved: TIROSINT — Original Application (IBSA Pharma Inc.)
FDA approved TIROSINT (levothyroxine sodium) from IBSA Pharma Inc. as an Original Application (NDA021924) for replacement therapy in thyroid…