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21-318 S-016 - accessdata fda

21-318 S-016 - accessdata fda 2025

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The document outlines the approval package for a supplemental new drug application (NDA 21-318/S-016) for Forteo (teriparatide) 3ml Cartridge, submitted by Eli Lilly and Company. The approval, dated June 25, 2008, introduces a new pre-filled pen-injector designed for teriparatide cartridges with a lower nominal fill volume. It includes various reviews such as chemistry, microbiology, and labeling assessments, highlighting improvements in usability and safety measures. The document emphasizes the importance of clear labeling to prevent medication errors and provides detailed instructions for use and storage of the product.

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Why is the approval of the FDA important?

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nations food supply, cosmetics, and products that emit radiation.

Do all drugs need to be FDA approved?

FDA Approval is Required by Law Federal law requires all new drugs in the U.S. be shown to be safe and effective for their intended use prior to marketing. However, some drugs are available in the U.S. even though they have never received the required FDA approval.

What does it mean if FDA approved?

The FDA approves new human drugs and biological products. This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards.

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When was Forteo approved by the FDA?

Approval Date: 11/26/2002.

What is the bioavailability of teriparatide?

The absolute bioavailability is approximately 95%. The peptide docHubes peak serum concentrations about 30 minutes after subcutaneous injection of a 20 mcg dose and declines to non-quantifiable concentrations within three hours. The volume of distribution following intravenous injection is approximately 0.12 L/kg.

What is FDA approval?

Before the FDA can approve a drug, the agency must determine whether the clinical data and other scientific information show that the drug is safe and effective for its intended use (for example, to prevent or treat a certain disease), and that the product can be made ing to federal quality standards.

How does FDA approval work?

A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the companys data and proposed labeling. If this independent and unbiased review establishes that a drugs health benefits outweigh its known risks, the drug is approved for sale.

21-318 S-016 - accessdata fda 2025

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