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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

886
Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
886
Glucagon-like Receptor Agonists01:24

Glucagon-like Receptor Agonists

462
Incretins include glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which stimulate insulin secretion post-meals. In type 2 diabetes, GIP's efficacy is reduced, making GLP-1 a viable drug target. GIP originates from preproGIP.
GLP-1, when administered in high doses intravenously, triggers insulin secretion, inhibits glucagon release, slows gastric emptying, reduces food intake, and restores normal insulin secretion. However, its rapid inactivation by...
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Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
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Direct-Acting Cholinergic Agonists: Therapeutic Uses01:11

Direct-Acting Cholinergic Agonists: Therapeutic Uses

1.1K
Direct-acting cholinergic agonists have many therapeutic uses in various medical fields. Choline esters, including acetylcholine, have limited clinical utility due to their non-selectivity and short duration of action. Still, acetylcholine and carbachol are applied topically during ophthalmologic surgery to induce miosis. Pilocarpine, a muscarinic and ganglionic stimulator, effectively treats open-angle glaucoma and alleviates xerostomia and dry mouth caused by radiotherapy or Sjögren...
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Adrenergic Agonists: Therapeutic Classification01:18

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Adrenergic agonists can be classified based on their therapeutic uses and mechanisms of action. They serve various purposes in clinical applications.
Vasopressor or pressor agents: They increase blood pressure and function as cardiac stimulants. Examples include endogenous catecholamines (norepinephrine and dopamine) and synthetic agents (phenylephrine).
Bronchodilators: β2-agonists can relax bronchial muscles and widen airways. They are commonly used for treating obstructive pulmonary...
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Related Experiment Video

Updated: Oct 6, 2025

Subretinal Implantation of RPE on a Carrier in Minipigs: Guidelines for Preoperative Preparations, Surgical Techniques, and Postoperative Care
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Somatrogon: First Approval.

Yvette N Lamb1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

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|January 18, 2022
PubMed
Summary
This summary is machine-generated.

Somatrogon (NGENLA®), a novel long-acting human growth hormone, offers a once-weekly treatment option for growth hormone deficiency. This development reduces patient treatment burden while maintaining efficacy, marking a significant milestone in pediatric care.

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Area of Science:

  • Endocrinology
  • Pharmacology
  • Biotechnology

Background:

  • Growth hormone deficiency (GHD) in pediatric patients often requires daily injections, posing a significant treatment burden.
  • Current therapies for GHD involve frequent administration of human growth hormone (hGH).
  • There is a need for improved therapeutic options with reduced dosing frequency for GHD management.

Purpose of the Study:

  • To summarize the key development milestones of somatrogon (NGENLA®).
  • To highlight the journey leading to the first regulatory approval of somatrogon for pediatric GHD.
  • To underscore the significance of a long-acting GHD treatment option.

Main Methods:

  • Development of somatrogon, a long-acting hGH utilizing C-terminal peptide technology.
  • Clinical evaluation of somatrogon for efficacy and safety in pediatric patients with GHD.
  • Regulatory submissions and review processes leading to market authorization.

Main Results:

  • Somatrogon demonstrated non-inferior efficacy compared to daily hGH therapy.
  • The once-weekly subcutaneous injection of somatrogon significantly reduced treatment burden.
  • First regulatory approval for somatrogon granted in Canada in October 2021 for pediatric GHD.

Conclusions:

  • Somatrogon represents a significant advancement in the treatment of pediatric growth hormone deficiency.
  • The once-weekly formulation offers a more convenient and potentially more adherent treatment option.
  • This development addresses a critical unmet need for improved GHD management strategies.