The Food and Drug Administration (FDA) has calculated the regulatory review period for the human drug product VEOZAH, which is used to treat menopause-related symptoms. This review period consists of 2,573 days, split between the drug testing phase (2,248 days) and the approval phase (325 days). The announcement is necessary due to requests for patent term extensions filed with the U.S. Patent and Trademark Office. The FDA invites comments and petitions regarding the accuracy of these dates and the diligence of the applicant during the review process.
Simple Explanation
The government checked how long it took to test and approve a medicine called VEOZAH, and they say it took a little over seven years. They're letting people know because there are some questions about how much extra time the medicine's special rules should last, and they want people to tell them if they agree or not.