FDA accepts Macugen NDA

Eyetech (EYET) and partner Pfizer (PFE) said the FDA accepted for filing their NDA for Macugen pegaptanib to treat exudative (wet) age-related macular degeneration (AMD). The NDA has Fast Track and Priority Review designations and a Dec. 17 PDUFA date. The FDA's Dermatologic & Ophthalmic drugs advisory committee will review the NDA on Aug. 27. ...