FDA advisory panel backs new female condom

GAITHERSBURG, Maryland (Reuters) - Female Health Co's new, potentially less costly version of its female condom, won crucial backing from a U.S. Food and Drug Administration advisory panel on Thursday.

The FDA panel of outside advisers, in a 15-0 vote, said the company's data supported FDA approval of the FC2 Female Condom as long as some changes were made to the product's label.

The company is seeking to market the new version as a method to prevent sexually transmitted diseases and pregnancy. The FDA usually follows its panel's advice.

"This will allow women in general to take even more control of their ability to protect themselves," said Michael Thomas, a panelist from the University of Cincinnati's College of Medicine.

Female Health's condom was first approved in 1993 and requires welding sheets of polyurethane to form a sheath, then welding rings at each end. The newer one, made of a synthetic rubber called nitrile, uses a simpler process similar to male condoms that should curb costs, the company told the panel.

FDA staff reviewers said they were concerned that the company did not conduct a new study to show how well FC2 actually prevented disease and pregnancy but instead compared it to the original version.

But panel members said the Female Health Co's data was acceptable and that further study was not needed for approval.

Shares of Female Health earlier closed up 3.8 percent, or 12 cents, at $3.38 on the American Stock Exchange.

(Editing by Carol Bishopric and Bernard Orr)