ARTICLE | Product Development

Cellegesic splits its panel

May 1, 2006 7:00 AM UTC

A day short of four years after it withdrew its second NDA for Cellegesic nitroglycerin ointment to treat anal fissure pain, Cellegy Pharmaceuticals Inc. convinced half of the members of an advisory committee that FDA should approve the product. The other half said the company should go back to the clinic.

Much of last week's Cardiovascular and Renal Drugs Advisory Committee meeting was a rehearsal of the four years of squabbling between CLGY (South San Francisco, Calif.) and FDA over how the company should design and interpret its trials. ...