The Food and Drug Administration (FDA) has announced its determination of the regulatory review period for the human drug BYLVAY. The FDA made this determination following a request from the U.S. Patent and Trademark Office for information related to patent term restoration. BYLVAY, approved for treating pruritis in patients aged 3 months and older with progressive familial intrahepatic cholestasis, underwent 1,868 days of regulatory review, including a testing phase of 1,625 days and an approval phase of 243 days. This notice invites anyone with information suggesting that these dates might be incorrect to submit their comments for consideration.
Simple Explanation
The FDA checked how long they tested and reviewed a medicine called BYLVAY before deciding it was safe for people to use, and they are letting others know how they calculated this time. If anyone thinks they made a mistake with these dates, they can say so, and the FDA will look into it.