See the DrugPatentWatch profile for vascepa

As of the latest updates, the FDA review timeline for Vascepa (icosapent ethyl) remains ongoing. In November 2020, the FDA accepted for review the New Drug Application (NDA) for Vascepa, which is being developed by Corbinian Pharmaceuticals, a subsidiary of Amarin Corporation.

According to the FDA's website, the Prescription Drug User Fee Act (PDUFA) date for the review is set for May 2023. This means that the FDA aims to complete its review and make a decision on the NDA by May 2023.

It's worth noting that the FDA's review process is typically lengthy and thorough, involving a comprehensive evaluation of the drug's safety and efficacy. The agency's reviewers will assess the available data on Vascepa, including the results of clinical trials, to determine whether the benefits of the drug outweigh its risks.

In the meantime, Corbinian Pharmaceuticals continues to work closely with the FDA to address any questions or concerns that may arise during the review process. The company has also been providing updates on its website and through investor relations channels.

For those interested in tracking the FDA's review timeline, DrugPatentWatch.com provides a useful resource for monitoring the status of pending applications, including the Vascepa NDA. The website aggregates information from various sources, including the FDA's website and other regulatory filings.

Sources:

1. FDA (2020). Vascepa (icosapent ethyl) NDA accepted for review. Retrieved from <https://www.fda.gov/drugs/news-updates-and-meetings/fda-accepts-new-drug-application-vascepa-icosapent-ethyl>
2. Corbinian Pharmaceuticals. (n.d.). Vascepa (icosapent ethyl) NDA update. Retrieved from <https://www.corbinianpharma.com/vascepa-icosapent-ethyl-nda-update/>
3. DrugPatentWatch.com. (n.d.). Vascepa (icosapent ethyl) NDA. Retrieved from <https://www.drugpatentwatch.com/patent/US20190315444>