FDA Drug Safety Communication: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death
[12-22-2010] The U.S. Food and Drug Administration (FDA) is informing the public that results from a study conducted in France —the Santé Adulte GH Enfant (SAGhE) study—found that persons with certain kinds of short stature (idiopathic growth hormone deficiency and idiopathic or gestational short sta (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 11, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news

UK children with growth disturbance given access to weekly injections
Approval of growth hormone somatrogon fast-tracked by medicines watchdog, replacing need for daily jabsThousands of children who fail to grow normally because of a hormone deficiency have been given access to a weekly injection for the condition after new guidance from the medicines watchdog.Children with the disorder, known as growth disturbance, have previously required daily injections of the growth hormone somatropin to ensure their healthy development. But afast-track assessment by the National Institute for Health and Care Excellence (Nice) means patients can now use a more convenient weekly injection called somatrog...
Source: Guardian Unlimited Science - December 22, 2022 Category: Science Authors: Ian Sample Science editor Tags: Children's health National Institute for Health and Care Excellence NHS UCL (University College London) Medical research UK news Source Type: news

OPKO and Pfizer announce positive Phase 3 top-line results for somatrogon
OPKO Health Inc. (NASDAQ: OPK) and Pfizer Inc. (NYSE: PFE) announced that the global Phase 3 trial evaluating somatrogon dosed once-weekly in pre-pubertal children with growth hormone deficiency (GHD) met its primary endpoint of non-inferiority to daily GENOTROPIN® (somatropin) for injection, as measured by annual height velocity at 12 months. (Source: World Pharma News)
Source: World Pharma News - October 24, 2019 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

Accretropin (Somatropin Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 5, 2019 Category: Drugs & Pharmacology Source Type: news

Following FDA nod, Ferring plans launch for needle-free drug-delivery system
Ferring Pharmaceuticals said last week that the FDA approved its injectable somatropin product for four additional pediatric indications: idiopathic short stature, short stature associated with Turner syndrome, short stature born small for gestational age with no catch-up growth by 2 – 4 years and growth failure in short stature homeobox-containing gene deficiency. In connection with the new approvals, Ferring plans to launch a needle-free drug-delivery system for its somatropin product in September this year. Get the full story at our sister site, Drug Delivery Business News. The post Following FDA nod, Ferring plans ...
Source: Mass Device - July 23, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pediatrics Pharmaceuticals Regulatory/Compliance ferringpharmaceuticals Source Type: news

Zorbtive (Somatropin rDNA Origin for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 28, 2017 Category: Drugs & Pharmacology Source Type: news

Zomacton (Somatropin (rDNA origin) for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - October 30, 2017 Category: Drugs & Pharmacology Source Type: news

Norditropin (Somatropin Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 18, 2017 Category: Drugs & Pharmacology Source Type: news

Nutropin Depot (Somatropin (rDNA origin) for Inj) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 7, 2017 Category: Drugs & Pharmacology Source Type: news

Nutropin AQ (Somatropin (rDNA origin)) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 7, 2017 Category: Drugs & Pharmacology Source Type: news

Nutropin (Somatropin (rDNA origin) for Inj) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 7, 2017 Category: Drugs & Pharmacology Source Type: news

Tev-Tropin (Somatropin, rDNA Origin, for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - July 3, 2017 Category: Drugs & Pharmacology Source Type: news

Saizen (Somatropin Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - May 22, 2017 Category: Drugs & Pharmacology Source Type: news

Serostim (Somatropin (rDNA origin)) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 15, 2016 Category: Drugs & Pharmacology Source Type: news

Genotropin (Somatropin [rDNA origin]) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 15, 2016 Category: Drugs & Pharmacology Source Type: news