Patent extension requests
Executive Summary
FDA review periods for three drugs determined. Merck's Prinivil (lisinopril) had a review period of 2,373 days (1,751 during IND and 622 during NDA); Merck is seeking 676 days of patent extension. Sterling's Corotrope (milrinone lactate) review period was 2,205 days (1,287 during IND and 918 during NDA); the company is seeking 730 days of patent extension. Kendall McGaw's Ucephan (sodium benzoate) had a 2,871 day review (2,058 IND; 813 NDA). Kendall is also seeking 730 days of patent extension. The Patent Office makes the final determination of the length of extension.