Ozempic

Essay Instructions:

1. Prepare as a Word document a BRIEF 1–2-page paper (between 500-800 words not including title & Reference page) of the newly approved drug by the FDA. Use APA format (7th edition) with a title page, reference page, and in-text citations. Your intended audience is a New Graduate RN. Upload the file to the assignment drop box on Canvas by the due date listed. Go to the FDA webpage and explore the process by which new drugs are developed and approved. https://www(dot)fda(dot)gov/patients/learn-about-drug-and-device-approvals/drug-development-process Choose a drug that has been approved in the last five years. Evaluate the process that the drug went through to gain approval. 2. The paper shall include the following 6 sections (paraphrase the headers to lower your Turnitin score): a. Commercial and generic name of the drug. FDA approved use(s) b. Mechanism of action(s), Likely adverse effects, toxicity, safety concerns. c. How long did this drug take from development to approval? Briefly describe the process. Were there any pauses or hurdles in the clinical trial phase? Why? How did the researchers overcome these issues, if any? d. What kind of marketing campaign was done for the release of this drug? How much does it cost? Is there a cost difference outside the United States? e. How do patients report problems with the drug? f. Summary: Reflect on any part of the approval process that got your attention. Would you want to take this drug yourself? Do you feel the drug is safe? 3. Do not copy and paste: Use your own words. It is essential to demonstrate your understanding of the medication

Essay Sample Content Preview:

Ozempic (Semaglutide): A Newly Approved FDA Drug Student’s Name Institution of Affiliation Course Instructor Date Ozempic (Semaglutide): A Newly Approved FDA Drug Semaglutide, sold under the name of Ozempic, is categorized under the GLP-1 receptor agonists, mainly used for treating Type 2 Diabetes Mellitus (T2DM) in adults. It is an injectable drug which was first endorsed by the FDA in 2017; it has been used to treat obesity and overweight in patients besides enhancing weight loss practices comprising of diet and exercise. The current paper discusses the strategic development of Ozempic, including the approval process and the marketing strategy, with a specific focus on safety profiles targeting new graduate RNs. Mechanism of Action, Adverse Effects, and Safety Concerns Ozempic is a GLP-1 receptor agonist like some other medications; it helps to manage type 2 diabetes by mimicking a hormone that increases the insulin secretion from pancreatic cells and decreases the secretion of glucagon from liver cells and also reduces the rate of gastric emptying, which leads to lowering of blood glucose level (Chudleigh & Bain, 2020). Other minor side effects include stomach upsets such as nausea, diarrhoea and vomiting, which are derived from the use of the tablets, but they fade after several days. Some of the severe side effects may include inflammation of the pancreas, thyroid gland cancer or kidney diseases. It should also be borne in mind that thyroid cysts are contraindicated in patients with a history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome. Drug Developmen...

Updated on November 23, 2024

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