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This document informs manufacturers about the FDA's requirement for levothyroxine sodium products to meet specific potency specifications to ensure quality throughout their shelf-lives.
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How to fill out levothyroxine sodium product specification
How to fill out Levothyroxine Sodium Product Specification Notification
01
Obtain the Levothyroxine Sodium Product Specification Notification form from the appropriate regulatory authority.
02
Fill in the product name and dosage form at the top of the form.
03
Provide the manufacturer's details including name, address, and contact information.
04
List the specifications of Levothyroxine Sodium, including strength, purity, and any active ingredients.
05
Indicate the storage conditions and shelf life of the product.
06
Attach any relevant documentation such as quality control test results.
07
Review the completed form for accuracy and completeness.
08
Submit the form to the designated regulatory authority either electronically or via mail.
Who needs Levothyroxine Sodium Product Specification Notification?
01
Pharmaceutical companies manufacturing Levothyroxine Sodium products.
02
Healthcare providers needing to prescribe Levothyroxine Sodium to patients.
03
Regulatory authorities requiring documentation for drug approval or monitoring.
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People Also Ask about
What is levothyroxine sodium information?
Levothyroxine is used to treat hypothyroidism (condition where the thyroid gland does not produce enough thyroid hormone). It is also used with surgery and radioactive iodine therapy to treat thyroid cancer. Levothyroxine is in a class of medications called hormones.
What are the guidelines for levothyroxine doses?
Adults and children older than 12 years of age (growth and puberty complete)—Dose is based on body weight and must be determined by your doctor. The dose is usually 1.6 microgram (mcg) per kilogram (kg) of body weight per day but may be less in older adults. Your doctor may adjust your dose as needed or tolerated.
What is the problem with levothyroxine?
Levothyroxine can raise your risk of bone loss. Thyroid hormones affect how strong your bones are. It can also lower your bone mineral density (BMD), which measures the strength of your bones. Both bone loss and low BMD can raise your risk of bone fractures.
Has levothyroxine been recalled by the FDA?
On 12/18/2024, Viatris manufacturer for Mylan recalled LEVOTHYROXINE SODIUM 112 MCG due to Superpotent Drug and Subpotent Drug: potency failures obtained. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.
Why was levothyroxine taken off the market?
Mylan Pharmaceuticals Inc. (a Viatris company) is conducting a recall at the retailer level of the below listed lots of Levothyroxine Sodium Tablets USP, packaged in bottles. These lots are being recalled out of an abundance of caution due to assay results that are either atypical or out of specification.
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What is Levothyroxine Sodium Product Specification Notification?
Levothyroxine Sodium Product Specification Notification is a document that outlines the specifications, quality standards, and regulatory compliance for the Levothyroxine Sodium product to ensure safety and efficacy.
Who is required to file Levothyroxine Sodium Product Specification Notification?
Manufacturers and distributors of Levothyroxine Sodium must file the Product Specification Notification to ensure their product meets regulatory standards.
How to fill out Levothyroxine Sodium Product Specification Notification?
To fill out the notification, one must provide detailed information about the product's composition, manufacturing process, quality control measures, and compliance with regulatory guidelines.
What is the purpose of Levothyroxine Sodium Product Specification Notification?
The purpose is to formally communicate the product's specifications and ensure that it adheres to necessary safety, quality, and effectiveness standards set by regulatory bodies.
What information must be reported on Levothyroxine Sodium Product Specification Notification?
The report must include product formulation, dosage form, strength, packaging details, stability data, labeling information, and any relevant clinical data.
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