New Drug Application (NDA)

Definition

The New Drug Application (NDA) is a comprehensive document submitted to the U.S. Food and Drug Administration (FDA) by drug companies seeking approval for a new drug. The NDA includes data from animal and human clinical trials, pharmacokinetics, toxicology, dosage, and manufacturing information. Approval of the NDA by the FDA provides the green light for the drug to be marketed to the public.

Phonetic

New Drug Application (NDA) would be phonetically transcribed as: new – /njuː/drug – /drʌg/application – /ˌæplɪˈkeɪʃən/(NDA) – /ˌɛnˈdiːˈeɪ/ Please note that this transcription uses the International Phonetic Alphabet (IPA) and represents General American English pronunciation. Different accents and dialects will have variations.

Key Takeaways

1. New Drug Application (NDA): The NDA is the final step in the drug approval process, which is managed by the U.S. Food and Drug Administration (FDA). The NDA presents all the findings about a particular drug to demonstrate its safety and efficacy. The FDA then reviews the NDA before making a decision whether or not to approve the drug for public use.
2. Content of NDA: The NDA includes a wide variety of information about the drug, such as preclinical and clinical test results, data regarding the drug’s behavior in the body, an outline of manufacturing methods, proposed labeling, and the measures taken for quality control.
3. Timeline and cost: The entire process of drug development to NDA filing is lengthy and expensive. It often takes about 10 years and can cost over 2 billion USD, according to some estimates. Despite these factors, the successful approval of a NDA means that a new and potentially life-saving drug is available to patients.

Importance

The New Drug Application (NDA) is a crucial term in business and finance, particularly within the pharmaceutical industry. It represents the final step in the drug approval process carried out by the U.S. Food and Drug Administration (FDA). Through the NDA, drug developers formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. This application is the vehicle used by drug companies to communicate to the FDA significant scientific and regulatory information about the drug. The FDA’s approval of an NDA signifies that it deems the drug safe and effective for public use, and it allows the drug company to market and distribute the drug, indicating possible return on investment for the company. Hence, the NDA carries major financial implications for both the drug’s developers and potential investors.

Explanation

The New Drug Application (NDA) plays a crucial role in the drug development process, primarily serving as the definitive step that a drug sponsor takes to seek approval from the Food and Drug Administration (FDA) to commercialize a new pharmaceutical product in the United States. The fundamental purpose of the NDA is to demonstrate to the FDA that the proposed drug is safe for use, effective for its intended use, appropriately labeled, and manufactured under stringent quality controls. This crucial phase in drug development allows the FDA to evaluate whether the new product can be brought out to the market.Moreover, the NDA also plays a crucial role in ensuring that consumers are fully informed about a new drug. It includes complete data gathered during the drug’s testing phases, proposed labeling information to ensure the drug is used safely and effectively and how it will be manufactured, processed, and packaged to maintain its quality. Hence, the NDA is the catalyst for a pharmaceutical product’s journey to the market where it provides health benefits for people, and consequently, commercial returns for the company that developed it.

Examples

1. Pfizer’s New Drug Application for Palbociclib: In 2014, the pharma giant Pfizer submitted an NDA to the U.S. Food and Drug Administration (FDA) for its drug Palbociclib, intended for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Following its review, the FDA granted accelerated approval in 2015, subsequently extending it to additional patient populations based on further submitted studies.2. Gilead Sciences and the NDA for Remdesivir: In August 2020, Gilead Sciences submitted an NDA to the FDA for Veklury (Remdesivir), an antiviral medication to treat COVID-19 in hospitalized patients. After an emergency use authorization was granted by the FDA earlier in May, the NDA submission led to its final approval as the first treatment for COVID-19 by the FDA in October 2020.3. Johnson & Johnson’s Spravato (Esketamine): This nasal spray, utilized for treatment-resistant depression, had its NDA accepted by the FDA in August 2018. The application included safety and efficacy data from a phase III clinical trial, following which approval was granted in March 2019 for use in conjunction with an oral antidepressant in adults with treatment-resistant depression.

Frequently Asked Questions(FAQ)

Related Finance Terms

• Food and Drug Administration (FDA)
• Clinical Trials
• Drug Approval Process
• Investigational New Drug (IND)
• Biologics License Application (BLA)

Sources for More Information

• U.S. Food and Drug Administration
• National Center for Biotechnology Information
• Clinical Leader
• CenterWatch