Regulatory: P&G, GeoPharma, Ilex, Inex

The FDA has said it is unclear whether a testosterone patch for boosting sexual desire in women, being developed by Proctor & Gamble, produced meaningful benefit or was safe over the long term. Reviewers were set to ask an advisory panel if more safety studies are needed before approval of the patch, called Intrinsa, which is being developed with Watson Pharmaceuticals.

The FDA has approved GeoPharma's drug to treat mucositis, an inflammation in the mouth that may be caused by radiation or chemotherapy. The company's shares soared 140 percent, to US$10.66 on Nasdaq. An estimated 300,000 cancer patients in the United States suffer from mucositis associated with cancer treatments. The company said it estimates the oncology market potential for the drug, Mucotrol, is up to US$1 billion a year worldwide.

Medical experts have told the FDA that Ilex Oncology's new drug Clolar was "reasonably likely" to help children and young adults with acute lymphocytic leukaemia, but that trial data were not sufficient to show improvements in acute myeloid leukaemia. Ilex is seeking expedited approval for Clolar to treat severe childhood cases of both acute lymphocytic leukaemia and acute myeloid leukaemia. If the FDA ultimately approves Clolar, it would be the first leukaemia drug cleared initially for paediatric use in more than a decade.

Experts have voted unanimously against recommending FDA approval for Inex Pharmaceuticals and Enzon Pharmaceuticals's new drug to treat relapses of non-Hodgkin's lymphoma. They said patients' limited response to the drug, called Marqibo, was not strong enough to warrant an expedited approval.