Advicenne withdraws the application for registration of ADV7103 in the United States

The pharmaceutical company Advicenne has announced the voluntary withdrawal of its application for registration of its drug ADV7103 for the treatment of primary distal renal tubular acidosis in the United States. This decision stems from discussions with the U.S. Food and Drug Administration, which revealed the need for additional work in Chemistry, Manufacturing, and Quality Control that could not be completed within the current timeframe.

Although withdrawn from the US market, ADV7103, also known as Sibnayal®, is already authorized and marketed in the European Union, the United Kingdom, as well as in some Middle Eastern countries such as Saudi Arabia and the United Arab Emirates.