FDA turns down Cellegy's Cellegesic.(Tuesday, Dec. 28)(Food and Drug Administration)(Cellegy Pharmaceuticals Inc.)(Brief Article)

Shares of Cellegy Pharmaceuticals Inc. sank nearly 45 percent Dec 27, following news that the FDA issued a not approvable letter for the company's anal fissure product, Cellegesic South San Francisco-based Cellegy received the letter Dec. 23, and released the news shortly before the Christmas holiday. On the first open trading day following the letter, Michael Forrest, Cellegy's president and CEO, said the company believed a third Phase III trial provided sufficient data for approval, according to a special protocol assessment agreed upon with the FDA. The FDA's letter, he said, did specify a number of reasons as to why Cellegesic …